Methods for the detection and diagnosis of cancers associated with the overexpression of a PSMA receptor.

Description

1 / 47 “METHODS FOR THE DETECTION AND DIAGNOSIS OF CANCERS ASSOCIATED WITH THE OVEREXPRESSION OF A PSMA RECEPTOR” Field

[001] The present invention relates to methods for the detection and diagnosis of a cancer related to the overexpression of prostate-specific membrane antigen. Background

[002] Prostate cancer is the second most frequent malignant neoplasm in men worldwide and is the second most common cancer, accounting for 9.5% of all new cancers in 2018. The occurrence of prostate cancer varies and correlates with age, with an incidence between 30% of men aged 40 to 50 years and 50% to 80% of men aged 80 years or older. At initial presentation, 80% of patients have local disease, 12% have regional disease, and 4% have metastatic disease. Although the 5-year survival rate for patients with local or regional prostate cancer is 99%, the survival rate drops to about 30% in the case of metastatic disease.

[003] Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that is expressed in normal, benign, and malignant prostate tissues. PSMA membrane protein expression increases with prostate tumor aggressiveness, the presence of metastatic disease, and cancer recurrence. For example, PSMA membrane protein expression is 100 to 1,000 times higher in prostatic adenocarcinoma than in benign prostate tissue and increases with androgen deprivation, with higher protein levels in high-grade and castration-resistant prostate cancer. Although the level of PSMA expression is correlated with disease development, there are cases of prostate cancer in which no increase in PSMA expression is observed in biopsies. Petition 870260082387, dated 08 / 14 / 2026, page 8 / 101 2 / 47

[004] Current approaches to prostate cancer diagnosis include a combination of prostate-specific antigen (PSA) blood analysis, imaging using positron emission tomography (PET), and prostate tissue biopsy. PET imaging requires the use of an appropriate radiotracer.68 Ga-PSMA-11 is one of the most widely used radiotracers for obtaining PET images of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer and is part of standard clinical practice in many centers. Although it is possible to obtain PET images using current radiotracers, the images obtained have limited resolution. This means that small lesions may not be detected and lesions near organs involved in radiotracer excretion (e.g., bladder) may not be sufficiently delineated and identified as cancerous.When these lesions go undetected, the subsequent delay in treatment can lead to worse outcomes for the patient.

[005] There is still a need for prostate cancer diagnostic methods that have greater sensitivity and allow for better delineation of cancerous tissue from healthy tissue in patients. Summary of the Invention

[006] According to one aspect, the present invention provides a method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Petition 870260082387, dated 08 / 14 / 2026, p. 9 / 101 3 / 47 Formula (I) ii) obtain an image of the subject by means of PET imaging at least approximately 8 hours after administration of the Formula (I) compound.

[007] According to one aspect, the present invention provides a method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; and Formula (I) ii) obtain the subject image by means of PET imaging; and iii) determine the tumor-to-fund ratio (TTBR) of one or more lesions detected by means of imaging in step ii); where the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in the subject is greater than approximately 40.

[008] According to one aspect, the present invention provides a method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Petition 870260082387, dated 08 / 14 / 2026, p. 10 / 101 4 / 47 Formula (I) ii) obtain an image of the subject by means of PET imaging at least approximately 8 hours after administration of the Formula (I) compound; iii) determine the tumor-to-fundus ratio (TTBR) of a lesion visualized by imaging in step ii); where the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in the subject is greater than approximately 40.

[009] According to another aspect, the present invention provides a method for imaging a lesion in a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtain the subject image by means of PET imaging; iii) determine the tumor-to-fund ratio (TTBR) of one or more lesions detected by imaging in step ii); in which the lesion has a tumor-to-fundus ratio (TTBR) of more than approximately 40.

[010] According to another aspect, the present invention provides a method for imaging a lesion in a cancer associated with the overexpression of a receptor. Petition 870260082387, dated 08 / 14 / 2026, p. 11 / 101 5 / 47 of PSMA in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtain an image of the subject by means of PET imaging at least approximately 8 hours after administration of the Formula (I) compound; iii) determine the tumor-to-fund ratio (TTBR) of one or more lesions detected by imaging in step ii); in which the lesion has a tumor-to-fundus ratio (TTBR) of more than approximately 40.

[011] According to one aspect, the present invention provides a method for the detection and / or diagnosis of a cancer associated with PSMA overexpression in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; and ii) obtain an image of the subject by means of PET imaging at least once between approximately 30 minutes and approximately 36 hours after administration of the compound of Formula (I); Formula (I) in which cancer imaging has a higher resolution compared to Petition 870260082387, dated 08 / 14 / 2026, p. 12 / 101 6 / 4768Ga-PSMA-11 administered under standard treatment conditions.

[012] In certain embodiments, the dose of the compound of Formula (I) or of a salt thereof complexed with 64Cu is about 100 MBq. In other embodiments, the dose of the compound of Formula (I) or of a salt thereof complexed with 64Cu is about 150 MBq. In other embodiments, the dose of the compound of Formula (I) or of a salt thereof complexed with 64Cu is about 200 MBq. In other embodiments, the dose of the compound of Formula (I) or of a salt thereof complexed with 64Cu is about 300 MBq.

[013] In certain modalities, subject imaging occurs approximately 8 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 10 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 12 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 16 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 18 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 20 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 24 hours after administration of the Formula (I) compound complexed with 64Cu.In certain modalities, subject imaging occurs approximately 28 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 30 hours after administration of the Formula (I) compound complexed with 64Cu. In certain modalities, subject imaging occurs approximately 36 hours after administration. Petition 870260082387, dated 08 / 14 / 2026, page 13 / 101 7 / 47 administration of the compound of Formula (I) complexed with 64Cu.

[014] In certain modalities, the tumor-to-fund ratio (TTBR) is greater than approximately 45. In some modalities, the TTBR is greater than approximately 50. In some modalities, the TTBR is greater than approximately 55. In some modalities, the TTBR is greater than approximately 60. In some modalities, the TTBR is greater than approximately 65. In some modalities, the TTBR is greater than approximately 70. In some modalities, the TTBR is greater than approximately 75. In some modalities, the TTBR is greater than approximately 80. In some modalities, the TTBR is greater than approximately 85. In some modalities, the TTBR is greater than approximately 90. In some modalities, the TTBR is greater than approximately 95. In some modalities, the TTBR is greater than approximately 100. In some modalities, the TTBR is greater than approximately 105. In some disciplines, the TTBR is greater than approximately 110. In some disciplines, the TTBR is greater than approximately 115. In some disciplines, the TTBR is greater than approximately 120. In some disciplines, the TTBR is greater than approximately 125.In some modalities, the TTBR is greater than about 130. In some modalities, the TTBR is greater than about 140. In some modalities, the TTBR is greater than about 145. In some modalities, the TTBR is greater than about 150. In some modalities, the TTBR is in the range of about 40 to about 150. In other modalities, the present invention also contemplates a TTBR in a range between the values ​​mentioned above.

[015] According to another aspect, the present invention provides a method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Petition 870260082387, dated 08 / 14 / 2026, p. 14 / 101 8 / 47 Formula (I) ii) obtain an image of the subject by means of PET imaging at least approximately 8 hours after administration of the Formula (I) compound; in which cancer imaging has a higher resolution compared to 68Ga-PSMA-11 administered under standard treatment conditions.

[016] According to another aspect, the present invention provides a method for the detection and / or diagnosis of a cancer associated with PSMA overexpression in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; and ii) obtain an image of the subject by means of PET imaging between approximately Formula (I) in which cancer imaging has a higher resolution compared to 68Ga-PSMA-11 administered under standard treatment conditions.

[017] The inventors of the present invention have discovered that images obtained according to a method of the present invention allow for higher resolution imaging when compared to methods that employ a standard treatment radiotracer (SOC) for imaging cancers that overexpress PSMA. Petition 870260082387, dated 08 / 14 / 2026, page 15 / 101 9 / 47

[018] The SOC radiotracer for PET imaging of PSMA-overexpressing cancers is a compound containing 68Ga. In certain modalities, the (68)Ga-containing compound is 68GaPSMA-11, as described below:

[019] Another radiotracer used for PET imaging of cancers that overexpress PSMA is a compound containing 18F. In certain modalities, the 18F-containing compound is 18F-DCFPyL (Pylarify®), as described below: The

[020] PET images show the absorption and localization of the radiotracer in body locations. The radiotracer, comprising a compound capable of binding to a target (e.g., a PSMA receptor) and a positron-emitting radioisotope, localizes to locations that overexpress the PSMA receptor and are indicative of cancer. Since the radioisotope decays with the emission of a positron, the detection of the emitted positrons corresponds to the localization of the cancer. PET images can then be superimposed on other imaging modalities that reveal structural information, e.g., computed tomography scans, to provide information about the location of the cancer. The intensity of the signals in a Petition 870260082387, dated 08 / 14 / 2026, p. 16 / 101 10 / 47 A specific region of interest indicates to the reader the relative amount of radiotracer that has accumulated in a particular location, with signals of greater intensity (or “brightness”) due to the greater accumulation of the radiotracer and correlated with the presence of cancer. A measure of intensity is the standardized uptake value (SUV), which is defined as the ratio between the radioactivity in a region of interest and the radioactivity injected into the subject's entire body. Higher SUVs indicate areas of greater “brightness” and therefore radioactivity. Greater contrast between regions of interest, i.e., higher SUVs, leads to higher resolution images. SUVs between images can be compared by first determining specific values, including maximum uptake values ​​(SUVmax), average uptake values ​​(SUVaverage), median uptake values ​​(SUVmedian), values ​​relative to the patient's body weight (SUVbw), values ​​relative to the patient's BMI (SUVbmi), and the like.Another measure of signal intensity is the tumor-to-background ratio (TTBR), which is the ratio between a signal attributed to the tumor associated with cancer and a signal attributed to the “background” or healthy tissue of the same subject. Using TTBR as a way to compare the absorption of the compound in Formula (I) can offer significant advantages over other intensity measures, for example, SUVmax and SUVmean, because the calculation of TTBR takes into account the background intensity of the image.

[021] To correctly identify cancer based on images obtained through PET imaging, images with sufficient resolution and / or contrast are necessary. The present inventors have discovered that methods comprising the administration of a compound of Formula (I) complexed with 64Cu provide images of higher resolution and / or contrast when compared to a SOC radiotracer, for example, a radiotracer comprising a radioisotope 68Ga or 18F. Higher contrast images can be obtained with the administration of the compound of Formula (I) complexed with 64Cu, since the present inventors Petition 870260082387, dated 08 / 14 / 2026, p. 17 / 101 11 / 47 demonstrated that the localization of the compound of Formula (I) in tumor sites that overexpress the PSMA receptor and the subsequent generation of images occur at a higher rate than other radiotracers, i.e., the proportion of the compound in the tumor site and the background is greater. As higher resolution and / or contrast images can be obtained, specifically contrast, cancerous lesions that would otherwise be overlooked can be detected (e.g., due to poor localization of the radioisotope complex and the low TTBR values ​​obtained). Higher resolution images also allow the detection of smaller cancerous lesions, especially smaller lesions that are close to each other or to organs involved in product elimination (e.g., bladder and kidneys).

[022] Without wanting to get bogged down in theory, the current inventors believe that the higher resolution and / or contrast of the images obtained when using the Formula (I) compound complexed with 64Cu is due, in part, to the longer half-life and smaller positron gap (t1 / 2 = 12.7 hours; mean positron gap = 0.56 mm for 64Cu) when compared to a SOC68Ga-PSMA-11 radiotracer (t1 / 2 = 68 minutes; mean positron gap = 3.5 mm for 68Ga) or 18F-DCFPyL (t1 / 2 = 109 minutes, mean positron gap < 1 mm for 18F). The 12.7-hour half-life of 64Cu allows for centralized fabrication of the Formula (I) radiolabeled compound with a product shelf life of up to 2 days.The longer half-life allows PET imaging from 1 to 72 hours after administration, which offers greater flexibility in terms of patient scheduling and may relate to the detection of additional lesions due to increased standardized uptake values ​​(SUV) in lesions relative to the background after biological clearance of the tracer from organs over time. The higher resolution of the images obtained according to the methods disclosed in this document is also due to the nature of the Formula (I) compound, i.e., the Formula (I) compound contains two molecules that are capable of targeting and binding to the receptor of interest. Furthermore, the physical properties of the Formula (I) compound... Petition 870260082387, dated 08 / 14 / 2026, p. 18 / 101 12 / 47 (I) allow greater binding at the target site and sufficient release of the radiotracer to provide greater contrast between tumor sites and healthy tissue.

[023] The positron gap refers to the distance traveled by an emitted positron before losing all its kinetic energy and being annihilated by an electron. As a result, the annihilation points form a uniform distribution around the actual emission point, thus causing image blurring for positron gaps larger than the intrinsic spatial resolution of the system. Because the 68Ga isotope has a much larger positron gap, the distribution of positron-electron annihilation events is subsequently larger, and the area over which these events are detected (and imaged) is also larger and more diffuse. This results in lower resolution images.

[024] A common measure of intensity in PET imaging is the standardized maximum capture value (SUVmax). In certain embodiments, the maximum SUV (SUVmax) obtained from images produced according to the methods disclosed in this document is greater than the value obtained from comparable images using a SOC radiotracer. In certain embodiments, the maximum SUV (SUVmax) obtained from images produced according to the methods disclosed in this document is greater than the value obtained from comparable images using a SOC radiotracer comprising 68Ga. In certain embodiments, the maximum SUV (SUVmax) obtained from images produced according to the methods disclosed in this document is greater than the value obtained from comparable images using a SOC radiotracer comprising 18F.In certain embodiments, the SUVmax assigned to the Formula (I) compound complexed with 64Cu is about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45% or about 50% greater than the same value according to a radiotracer comprising 68Ga. In certain embodiments, the SUVmax assigned to the Formula (I) compound complexed with 64Cu is about 10%, about 15%, about 20%,. Petition 870260082387, dated 08 / 14 / 2026, p. 19 / 101 13 / 47 approximately 25%, approximately 30%, approximately 35%, approximately 40%, approximately 45%, or approximately 50% greater than the same value according to a radiotracer comprising 18F. As seen in Figure 4, the SUVmax of lesions imaged according to the methods described in this document (i.e., after administration of 64Cu-Sar-bisPSMA) is greater than when the same subject receives a radiotracer comprising 68Ga. The highest SUVmax in images obtained according to the methods disclosed in this document was reported by two different image readers. Given the greater signal intensity (SUVmax), the inventors believe that the methods disclosed in this document allow for a more efficient and effective diagnosis of PSMA receptor-associated cancers.

[025] Figure 7 also shows an increase in SUVmax of images taken of the same subject, where the image on Day 0 showed an SUVmax of 20.8 and the same image repeated the following day (i.e., Day 1) showed an SUVmax of 50.4. The current inventors believe that the flexibility in imaging a patient after administration of the Formula (I) compound complexed with 64Cu allows for more effective diagnosis of cancers associated with a PSMA receptor, since lesions associated with these cancers that are not visualized by imaging on the same day are often not detected when currently available ligands and radioisotopes are used. Because subject imaging can be performed the day after administration of the Formula (I) compound, the patient may feel more comfortable, which in turn increases patient adherence to the procedure.The current inventors discovered that the maximum uptake value is greater when a subject is imaged one day after imaging the Formula (I) compound complexed with 64Cu. This can be seen in Figure 8, where imaging of the subject on the day of administration (Figure 8A) does not clearly visualize a lesion, but repeat imaging the following day (Figure 8B) successfully identifies a lesion in the same subject. Petition 870260082387, dated 08 / 14 / 2026, page 20 / 101 14 / 47

[026] Another measure of intensity in PET imaging is the standardized mean uptake value (SUVmean). In other embodiments, the mean SUV (SUVmean) obtained from images produced according to the methods disclosed in this document is greater than the value obtained from comparable images using a SOC radiotracer comprising 68Ga or 18F. In certain embodiments, the SUVmean assigned to the Formula (I) compound complexed with 64Cu is about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45% or about 50% greater than the same value according to a radiotracer comprising 68Ga. This can be seen in Figure 2 (B) and (D), which clearly shows the lesions visualized with a higher intensity, compared to the same lesions visualized with an existing 68Ga protocol in Figure 2 (A) and (C).As seen in Figure 5, the mean SUV (Sud-Maximum Uptake) of lesions visualized according to the methods described in this document (i.e., after administration of 64Cu-Sar-bisPSMA) is higher than when the same subject receives a radiotracer comprising 68Ga. The higher mean SUV in images obtained according to the methods disclosed in this document was reported by two different image readers. Since the mean uptake value (SUV-Maximum Uptake) attributed to the methods disclosed in this document is higher than that according to existing methods, the inventors believe that the methods in this document may provide an improved process for the diagnosis of PSMA receptor-associated cancer.

[027] The inventors believe that PET images obtained according to the methods of the present invention have higher resolution due to the nature of the radioisotope (i.e., 64Cu) that is complexed with the compound of Formula (I). As disclosed in this document, the methods involve imaging the subject at least once between approximately 30 minutes and approximately 36 hours after administration of the radiotracer. In comparison, the imaging methods according to the Petition 870260082387, dated 08 / 14 / 2026, p. 21 / 101 Current SOC models involve administering a dose of 68Ga-PSMA-11 with radioactivity between 111 MBq and 259 MBq (according to the FDA), with images obtained after a period of approximately 1 hour. Since the 68Ga isotope has a shorter half-life (t1 / 2), the time between administration and imaging must be optimized to ensure sufficient image quality. The current inventors have found that, because the 64Cu radioisotope used in the methods disclosed in this document has a longer half-life, a longer time between administration and imaging is possible. Without wanting to be overly theoretical, the current inventors believe that increasing the time between administration of the radiotracer compound and subsequent imaging provides a greater opportunity for the radiolabeled complex to localize to cancer sites and for any unbound radiotracer to be eliminated from the subject.This, in turn, allows for higher resolution imaging, as the contrast between the radiotracer placement sites and the background is greater. This can be seen in Figure 6, which shows the average ratio between the tumor and the background, where the average ratio is higher in images obtained after administration of 64Cu-Sar-bisPSMA compared to administration of 68Ga-PSMA-11.

[028] The present inventors also believe that the highest maximum, average, and median SUV obtained as a result of imaging after administration of the Formula (I) compound complexed with 64Cu is also, at least partially, attributed to the dimeric nature of the Formula (I) compound. As seen in the structure of Formula (I), the compound contains two lysine-urea-glutamate motifs linked to the sarcophagin chelator via linking groups. As the corresponding monomeric compound, i.e., a sarcophagin with a single lysine-urea-glutamate motif (and shown below), shows less uptake and retention when compared to the dimeric compound of Formula (I) disclosed in this document. Petition 870260082387, dated 08 / 14 / 2026, p. 22 / 101 16 / 47

[029] Figure 1 shows that the compound of Formula (I) has greater uptake and retention in tumors when compared to the corresponding monomeric compound containing a single lysine-urea-glutamate motif.

[030] In some embodiments, the dose of a compound of Formula (I) or of a salt thereof complexed with 64Cu is about 200 MBq.

[031] In certain forms, the cancer is prostate cancer.

[032] In other modalities, the cancer is a primary prostate cancer. In some modalities, the cancer is a prostate cancer associated with biochemical recurrence.

[033] In certain modalities, the imaging is a combined PET / CT imaging.

[034] In some modalities, subject imaging occurs approximately 8 hours, approximately 9 hours, approximately 10 hours, approximately 11 hours, approximately 12 hours, approximately 13 hours, approximately 14 hours, approximately 15 hours, approximately 16 hours, approximately 17 hours, approximately 18 hours, approximately 19 hours, approximately 20 hours, approximately 21 hours, approximately 22 hours, approximately 23 hours, approximately 24 hours, approximately 25 hours, approximately 26 hours, approximately 27 hours, approximately 28 hours, approximately 29 hours, approximately 30 hours, approximately 31 hours, approximately 32 hours, approximately 33 hours, approximately 34 hours, approximately 35 hours, or approximately 36 hours after administration of the Formula (I) compound complexed with 64Cu. In other modalities, subject imaging occurs Petition 870260082387, dated 08 / 14 / 2026, page 23 / 101 17 / 47 approximately 12 hours, approximately 24 hours, or approximately 36 hours after administration of the compound of Formula (I) complexed with 64Cu.

[035] In certain modalities, the method includes an additional imaging step of the subject by means of PET imaging. In some modalities, the additional imaging step occurs approximately 4 hours, approximately 6 hours, approximately 8 hours, approximately 10 hours, approximately 12 hours, approximately 16 hours, approximately 18 hours, approximately 24 hours, approximately 30 hours, approximately 36 hours, approximately 42 hours, approximately 48 hours, approximately 54 hours and / or approximately 60 hours after the first imaging step.

[036] In certain modalities, the method also includes the magnetic resonance imaging or ultrasound imaging step.

[037] In certain modalities, the method also includes the step of determining the subject's PSA level.

[038] In certain modalities, cancer is present as one or more lesions in the subject. In some modalities, cancer is present in more than one lesion in the subject.

[039] In certain modalities, one or more lesions are present in the subject's prostate tissue. In certain modalities, more than one lesion is present in the subject's prostatic tissue. In certain modalities, more than one lesion is present in the subject's non-prostatic tissue.

[040] According to another aspect, the present invention provides a method for the detection and diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Petition 870260082387, dated 08 / 14 / 2026, p. 24 / 101 18 / 47 Formula (I) ii) obtain an image of the subject by means of PET imaging at least approximately 8 hours after administration of the Formula (I) compound.

[041] According to another aspect, the present invention comprises a method for the detection and diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtain the subject image by means of PET imaging; and iii) determine the tumor-to-fundus ratio (TTBR) of a lesion visualized by means of imaging; where the tumor-to-fundus ratio (TTBR) of a cancer-associated lesion in a subject, as detected by imaging in step ii), is greater than approximately 40.

[042] According to another aspect, the present invention comprises a method for the detection and diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof: Petition 870260082387, dated 08 / 14 / 2026, p. 25 / 101 19 / 47 i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtain an image of the subject by means of PET imaging at least approximately 8 hours after administration of the Formula (I) compound; iii) determine the tumor-to-fundus ratio (TTBR) of a lesion visualized by imaging; where the tumor-to-fundus ratio (TTBR) of a cancer-associated lesion in a subject, as detected by imaging in step ii), is greater than approximately 40.

[043] According to another aspect, the present invention provides a method for the detection and diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method comprising: i) administer to the subject a dose of between about 100 and about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; ii) obtain an image of the subject by means of PET imaging at least once between approximately 30 minutes and approximately 36 hours after administration of the compound of Formula (I); and iii) diagnose secondary cancer based on one or more images obtained in step ii), Petition 870260082387, dated 08 / 14 / 2026, page 26 / 101 20 / 47 where the cancer image is at a higher resolution compared to 68Ga-PSMA-11 administered under standard treatment conditions.

[044] The present inventors have discovered that administration of the Formula (I) compound complexed with 64Cu and subsequent PET imaging allows visualization of a secondary cancer. Secondary cancers are located in different (i.e., non-primary) sites and result from metastasis of the primary cancer. This can be seen in Figure 3, where imaging with the Formula (I) compound complexed with 64Cu, according to the methods disclosed in this document, clearly identifies a lesion, as seen in Figure 3(A), while imaging of the same subject with the comparative product 68Ga does not identify the same lesion. This is seen by the absence of a signal at the same location in Figure 3(B). Without wanting to get bogged down in theory, the inventors believe that the methods disclosed in this document allow for better detection and identification of PSMA receptor-associated cancers.Once identified, current methods also allow for a more effective and efficient diagnosis of cancer, as the subject's images show greater intensity, so that image readers can interpret and subsequently diagnose the cancer with greater certainty. Figure 9 also shows the identification of a secondary cancer (in the superdiaphragmatic area) in a subject, where imaging after administration of an 18F-labeled ligand revealed negative / equivocal results (SUVmax = 2.3) and imaging after administration of 64Cu-Sar-bisPSMA on the same day also showed negative results (SUVmax = 4.3). However, imaging of the same subject the following day (i.e., Day 1) clearly identified a lesion with an SUVmax value of 17.5, i.e., four times greater than when imaged the previous day. Petition 870260082387, dated 08 / 14 / 2026, page 27 / 101 21 / 47 Not wanting to adhere to theory, the current inventors believe that the methods disclosed in this document allow for next-day imaging of patients who have been administered a dose of 64Cu-Sar-bisPSMA. Current products and protocols for imaging and / or diagnosing PSMA receptor-associated cancer do not allow for next-day imaging due to the half-life of the radioisotope used, ligand and radioisotope shedding from the patient, ligand leakage from the radioisotope, and the general lack of stability of these ligands.

[045] In certain forms, the primary cancer is prostate cancer.

[046] In certain forms, secondary cancer is located in a non-prostate site.

[047] In some forms, the secondary cancer is in a lymph node. In other forms, the secondary cancer is in the bone, bladder, lungs, or liver.

[048] In certain modalities, secondary cancer is associated with biochemical recurrence.

[049] The inventors believe that the methods disclosed in this document allow for the diagnosis of secondary cancer. Since secondary cancer may have a lower density of PSMA receptors, increasing the time between administration of the 64Cu radiotracer and imaging allows for sufficient accumulation of the radiotracer in cancer sites with a lower density of PSMA receptors, so that images with sufficient resolution are obtained. The accumulation of a greater amount of radiotracer provides a better tumor-to-background ratio, resulting in images with higher contrast and higher resolution.

[050] Without wanting to get bogged down in theory, the current inventors believe that the use of the methods disclosed in this document allows for the detection and diagnosis of secondary cancer, which is not possible when the radiotracer SOC68Ga-PSMA11 is used under comparable conditions. In some modalities, imaging of Petition 870260082387, dated 08 / 14 / 2026, page 28 / 101 22 / 47 A PET scan of a subject with prostate cancer, according to the methods disclosed in this document, indicates PSMA overexpression in one or more lymph nodes and that secondary cancer is present in the lymph node.

[051] In certain modalities, the method also includes confirmation of secondary cancer by biopsy.

[052] According to another aspect, the present invention comprises a method for determining the TNM stage of prostate cancer in a subject, comprising the method i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or of a salt thereof complexed with 64Cu; ii) obtain an image of the subject using PET imaging; and iii) determine the TNM stage of the cancer based on one or more images obtained in step ii) and the ISUP grade of the tumor; where the ISUP grade of the tumor is determined before steps i) to iii).

[053] According to another aspect, the present invention provides a method for determining the TNM stage of prostate cancer in a subject, the method comprising i) administer to the patient a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or of a salt thereof complexed with 64Cu; ii) obtain an image of the subject by means of PET imaging at least approximately 8 hours after administration of the compound of Formula (I); and iii) determine the TNM stage of the cancer based on one or more images obtained in step ii) and the ISUP grade of the tumor; Petition 870260082387, dated 08 / 14 / 2026, page 29 / 101 23 / 47 where the ISUP grade of the tumor is determined before steps i) to iii).

[054] According to another aspect, the present invention provides a method for determining the TNM stage of prostate cancer in a subject, the method comprising i) administer to the patient a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or of a salt thereof complexed with 64Cu; ii) obtain an image of the subject by means of PET imaging at least once between approximately 30 minutes and approximately 36 hours after administration of the compound of Formula (I); and iii) determine the cancer stage based on one or more images obtained in step ii) and the ISUP grade of the tumor; where the ISUP grade of the tumor is determined before steps i) to iii).

[055] In certain modalities, subject imaging by PET imaging occurs approximately 12 hours after administration of the Formula (I) compound complexed with 64Cu. In other modalities, subject imaging by PET imaging occurs approximately 18 hours after administration of the Formula (I) compound complexed with 64Cu. In other modalities, subject imaging by PET imaging occurs approximately 24 hours after administration of the Formula (I) compound complexed with 64Cu. [05 6] In certain modalities, the ISUP grade of the tumor is Grade 1, Grade 2, Grade Petition 870260082387, dated 08 / 14 / 2026, p. 30 / 101 24 / 47 3, Grade 4, or Grade 5.

[057] In certain modalities, the ISUP grade of the tumor is determined by calculating the Gleason score. In certain modalities, the Gleason score is 6, 7, 8, 9, or 10.

[058] In certain modalities, the TNM stage of prostate cancer is selected from one or more of the following stages: TX, TO, T1, T2, T3, T4, NX, NO, N1, N2, N3, MX, MO or M1.

[059] According to another aspect, the present invention provides a method for reassessing the TNM stage of prostate cancer in a subject, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtain the subject image by means of PET imaging; iii) first determine the stage of prostate cancer based on one or more images obtained in step ii); and iv) repeat steps i) and ii) and determine the stage of prostate cancer based on one or more images obtained by imaging the subject after the second administration of the compound of Formula (I), according to step i).

[060] In certain modalities, reassessment of the TNM stage of prostate cancer in a subject is performed to determine the progression of the cancer in the subject.

[061] According to another aspect, the present invention provides a method for determining the progression of a cancer associated with the overexpression of a PSMA receptor in a subject, the method comprising: Petition 870260082387, dated 08 / 14 / 2026, page 31 / 101 25 / 47 i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtain the subject image by means of PET imaging; iii) first determine the TNM stage of prostate cancer based on one or more images obtained in step ii); and iv) repeat steps i) and ii) and determine the TNM stage of prostate cancer based on one or more images obtained by imaging the subject after the second administration of the compound of Formula (I) according to step i).

[062] According to another aspect, the present invention provides a method for reassessing the TNM stage of prostate cancer in a subject, the method comprising: i) administer to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtain an image of the subject by means of PET imaging at least once between approximately 30 minutes and approximately 36 hours after administration of the Formula (I) compound; iii) first determine the stage of prostate cancer based on one or more images obtained in step ii); and Petition 870260082387, dated 08 / 14 / 2026, page 32 / 101 26 / 47 iv) Repeat steps i) and ii) and determine the stage of prostate cancer based on one or more images after the second administration, according to step i).

[063] In certain modalities, the TNM stage of prostate cancer after reassessment is higher.

[064] In certain modalities, the TNM stage of prostate cancer after reassessment includes an N1, N2, or N3 stage.

[065] In certain modalities, the TNM stage of prostate cancer after reassessment is lower.

[066] In certain modalities, the TNM stage of prostate cancer after reassessment includes a T0, N0, or M0 stage.

[067] In another embodiment, prostate cancer is a metastatic castration-resistant prostate cancer (mCRPC) that expresses PSMA or is a progressive mCRPC despite prior androgen deprivation therapy and at least enzalutamide and / or abiraterone (or other androgen receptor pathway inhibitors). In another embodiment, prostate cancer is characterized by biochemical resistance in the subject. Brief Description of the Figures

[068] Figure 1. Ex vivo tumor uptake expressed as a percentage of injected activity per gram of tissue (% IAg) (mean + / - SEM, n=3 / group) in NSG mice bearing LNCap tumor after injection of monomeric [64Cu]Cu-SarPSMA (2 MBq, 0.9 nmol peptide) or dimeric [64Cu]Cu-Sar-bisPSMA (2 MBq, 0.2 nmol peptide). One hour after administration, the uptake of 64CuSar-bisPSMA is approximately twice that of the monomeric compound 64Cu-Sar-PSMA. Between 6 and 24 hours after administration, the amount of 64Cu-SarbisPSMA retained at the tumor site is much greater than the amount of 64CuSarPSMA retained under the same conditions. Petition 870260082387, dated 08 / 14 / 2026, p. 33 / 101 27 / 47

[069] Figure 2. Intraindividual comparison of PET / CT images obtained after administration of 68Ga-PSMA-11 (1A and 1C) and 64Cu-Sar-bisPSMA (1B and 1D) showing clearer lesion delineation and higher SUVmax.

[070] Figure 3. Detection of a secondary lesion in a subject's lymph node by PET / CT after administration of 64Cu-Sar-bisPSMA, as seen in Figure 2A. The comparative image of the same subject after administration of 68Ga-PSMA-11 is shown in Figure 2B, where no uptake was detected.

[071] Figure 4. SUVmax of concordant lesions detected by PET / CT after administration of 64Cu-Sarbis-PSMA and 68Ga-PSMA-11, as detected by (A) Reader 1 and (B) Reader 2. Both readers determined that the lesions detected after administration of 64Cu-Sarbis-PSMA showed a higher SUVmax than the same lesions after administration of 68Ga-PSMA-11.

[072] Figure 5. Mean SUV of concordant lesions detected by PET / CT after administration of 64Cu-Sar-bisPSMA and 68Ga-PSMA-11, as detected by (A) Reader 1 and (B) Reader 2. Both readers determined that the lesions detected after administration of 64Cu-Sar-bis-PSMA showed a higher mean SUV than the same lesions after administration of 68Ga-PSMA-11.

[073] Figure 6. Tumor / background ratio of concordant lesions detected by PET / CT after administration of 64Cu-SarbisPSMA and 68Ga-PSMA-11, as detected by (A) Reader 1 and (B) Reader 2. Both readers determined that the lesions detected after administration of 64Cu-SarbisPSMA had a higher tumor / background ratio.

[074] Figure 7.64Cu-SAR-bisPSMA PET showing a positive pelvic lymph node (LN; red circle, maximum intensity projection). CT-guided needle biopsy of the lesion was performed and was negative for PC. Subsequently, an excisional biopsy of the lesion was performed, which confirmed the presence of PC by histopathology. Imaging the following day (Figure 8B) showed an increase in SUVmax (value of Petition 870260082387, dated 08 / 14 / 2026, page 34 / 101 28 / 47 maximum standard capture) more than double compared to imaging on the same day (Figure 8A), from 20.8 on Day 0 to 50.4 on Day 1.

[075] Figure 8. Images from the following day (Figure 8B, i.e., images taken the day after administration of 64Cu-Sar-bisPSMA) of the superdiaphragmatic region of a subject who was administered 64Cu-Sar-bisPSMA. The lesion in this region of the subject was identified by three readers in the subject's imaging the day after administration of 64Cu-Sar-bisPSMA, while the same lesion was less apparent based on imaging from the same day (Figure 8A).

[076] Figure 9. PET / CT fusion images of a subject who was administered 18F-DCYPyL as SOC (Figure 9A, SUVmax = 2.3), showing negative / equivocal screening results. Same-day imaging (Figure 9B, SUVmax = 4.3) and next-day imaging (Figure 9C, SUVmax = 17.5) of the same subject who was administered 64Cu-Sar-bisPSMA. A lesion in the pelvic region was identified by imaging the day after administration of 64Cu-SarbisPSMA, where the same lesion was not visualized after same-day imaging of the subject after administration of 64Cu-Sar-bisPSMA.

[077] Figure 10. Administration of 64Cu-Sar-bisPSMA to a patient and PET imaging of the pelvic, extrapelvic (retroperitoneal) and prostatic bed regions on the same day (Figure 10A) and the following day (Figure 10B). As seen in Figure 10B, imaging of the patient the day after administration of 64CuSar-bisPSMA revealed more positive lesions and lesions more clearly visualized than those initially detected with same-day imaging, as seen in Figure 10A.

[078] Figure 11. Administration of 64Cu-Sar-bisPSMA to a patient and PET imaging of the pelvic, extrapelvic (retroperitoneal) and prostatic bed regions on the same day (Figure 11A) and the following day (Figure 11B). Both images show a lesion in the pelvic bone, with pelvic lymph nodes visualized only with imaging the following day. The mean SUVmax for the bone lesions and Petition 870260082387, dated 08 / 14 / 2026, page 35 / 101 29 / 47 pelvic lymph node counts increased from 9.8 (Figure 11A) to 20.0 (Figure 11B). A lesion in the prostatic bed was only visualized with imaging the following day, as seen in Figure 11B.

[079] Figure 12. Administration of 64Cu-Sar-bisPSMA and subsequent PET imaging of the subject's pelvic, extrapelvic (retroperitoneal) and prostatic bed regions on the day of administration (Figure 12A) and the following day (Figure 12B). Imaging on the following day showed additional positive lesions in the subject compared to imaging on the same day. Detailed Description

[080] Throughout this descriptive report and in the claims that follow, unless the context requires otherwise, the word “comprise” and variations such as “comprises” and “comprising” will be understood as implying the inclusion of a whole number or step or group of whole numbers or steps, but not the exclusion of any other whole number or step or group of whole numbers or steps.

[081] The term “about” or “approximately”, as used in this document, means that it is within an acceptable range of error for the specific value, as determined by a person skilled in the art, which will depend in part on how the value is measured or determined, i.e., the limitations of the measurement system.

[082] Unless defined otherwise, all technical and scientific terms used in this document have the same meaning commonly understood by a person skilled in the art to which the invention pertains. For the purposes of the present invention, the following terms are defined below.

[083] The compound of Formula (I), as defined in this document, is a sarcophagin attached to two lysine-urea-glutamate motifs by means of connectors and has the following structure: Petition 870260082387, dated 08 / 14 / 2026, p. 36 / 101 30 / 47

[084] The compound of Formula (I) is also known as Sar-bisPSMA.

[085] In certain forms, the compound of Formula (I) has the following structure:

[086] As used in this document, the compound 68Ga-PSMA-11 refers to a radioisotope 68Ga complexed to the compound PSMA-11 with the following structure:

[087] PSMA-11 complexed with a 68Ga radioisotope is also known as HBED-CC, HBED, PSMA-HBED or Prostamedix™.

[088] As used in this document, the compound 18F-DCFPyL (piflufolastat18F) refers to the DCFPyL compound complexed with a radioisotope 18F with the following structure: Petition 870260082387, dated 08 / 14 / 2026, p. 37 / 101 31 / 47

[089] The term “pharmaceutically acceptable salts” refers to salts that retain the desired biological activity of the compounds identified above, including pharmaceutically acceptable acid addition salts and base addition salts. Pharmaceutically acceptable acid addition salts of the compounds of Formula (I) may be prepared from an inorganic acid or an organic acid. Examples of such inorganic acids are hydrochloric acid, sulfuric acid, phosphoric acid, methanesulfonic acid, camphorated sulfonic acid, oxalic acid, maleic acid, succinic acid, citric acid, formic acid, hydrobromic acid, benzoic acid, tartaric acid, fumaric acid, salicylic acid, mandelic acid, and carbonic acid.Suitable organic acids may be selected from the aliphatic, cycloaliphatic, aromatic, heterocyclic carboxylic, and sulfonic classes of organic acids, such as, for example, formic, acetic, propionic, succinic, glycolic, gluconic, lactic, malic, tartaric, citric, fumaric, maleic, alkylsulfonic, and arylsulfonic acids. Pharmaceutically acceptable salts also include those in which the principal compound functions as an acid and reacts with an appropriate base to form, for example, sodium, potassium, calcium, magnesium, ammonium, and choline salts. Those skilled in the art will further recognize that acid addition salts may be prepared by reacting a compound with the appropriate inorganic or organic acid by various known methods. Alternatively, alkali and alkaline-earth metal salts may be prepared by reacting a compound with the appropriate base by a variety of known methods.Here are some other examples of acid salts that can be obtained by reaction with inorganic or organic acids: acetates, adipates, alginates, citrates, aspartates. Petition 870260082387, dated 08 / 14 / 2026, page 38 / 101 32 / 47 benzoates, benzenesulfonates, bisulfates, butyrates, camphorates, digluconates, cyclopentanepropionates, dodecylsulfates, ethanesulfonates, glucoheptanoates, glycerophosphates, hemisulfates, heptanoates, hexanoates, fumarates, hydrobromides, hydroiodides, 2-hydroxyethanesulfonates, lactates, maleates, methanesulfonates, nicotinates, 2-naphthalenesulfonates, oxalates, palmates, pectinates, persulfates, 3-phenylpropionates, picrates, pivalates, propionates, succinates, tartrates, thiocyanates, tosylates, mesylates and undecanoates. Additional information regarding pharmaceutically acceptable salts can be found in Remington's Pharmaceutical Sciences, 19th Edition, Mack Publishing Co., Easton, PA 1995. In the case of agents that are solids, it is understood by those skilled in the art that the inventive compounds, agents, and salts may exist in different crystalline or polymorphic forms, all of which must be within the scope of the present invention and the specified formulas.

[090] As used in this document, the term “cancer” broadly encompasses neoplastic diseases characterized by the abnormal growth of cells with the potential to invade or spread to other parts of the body. Cancer can be benign, meaning it does not spread to other parts of the body. Cancer can be malignant, meaning that cancerous cells can spread through the circulatory or lymphatic system. The term, as used in this document, includes all states of malignant, i.e., cancerous, diseases. Cancer can be present as a tumor. Thus, the term “tumor” is used generally to define any malignant, cancerous, or precancerous cell growth, and may include leukemias, but is particularly directed at solid tumors or carcinomas, such as melanomas, colon, lung, ovarian, skin, breast, pancreatic, pharyngeal, brain, prostate, CNS, and renal cancers (as well as other cancers).

[091] In one modality, the condition is breast cancer, colon cancer, lung cancer, ovarian cancer, prostate cancer, head and / or neck cancer. Petition 870260082387, dated 08 / 14 / 2026, page 39 / 101 33 / 47 neck or kidney, gastric, pancreatic, brain cancer or a hematological malignancy, such as lymphoma or leukemia.

[092] As used in this document, the term “standard of care” refers to a treatment that is the best known treatment for the condition. For prostate cancer, the current standard of care includes administering a dose of 68GaPSMA-11 with radioactivity between 111 MBq and 259 MBq (according to the FDA), with images obtained via PET imaging for diagnostic purposes after a period of approximately 1 hour.

[093] As used in this document, the term “detection” refers to the visualization of a disease in a patient. Disease detection may involve administering an agent to the patient and subjecting the patient to one or more imaging modalities, where one or more images taken of the patient are processed to display the location of the agent in the patient’s body. The imaging process for detection purposes may also include steps such as imaging the patient to determine a baseline image, an anatomical image, or similar, in order to allow comparison with images produced after administration of an agent.

[094] As used in this document, the term “diagnosis” refers to the detection and subsequent identification of a disease in a patient. The diagnosis of a disease may take into account one or more signs and symptoms exhibited by the patient and may include one or more examinations or tests, such as imaging, blood tests, or biopsies. For example, a disease may be diagnosed in a patient based on the signs and symptoms reported by the patient and the results of one or more imaging modalities, tissue biopsies, and blood tests to detect specific markers of the disease. In certain modalities, the methods disclosed in this document are used to diagnose cancer in a patient, where the methods include the use of PET imaging, biopsy, and / or Petition 870260082387, dated 08 / 14 / 2026, page 40 / 101 34 / 47 patient blood tests.

[095] As used in this document, the term “prognosis” refers to the prediction of the course of a disease in a patient who has been diagnosed with a particular disease. For example, when a patient has been diagnosed with a particular disease, the information obtained in the diagnostic process can be used to assess the extent or severity of the disease, which, in turn, can be used to form a specific prognosis for the patient. In certain modalities, the methods disclosed in this document allow the imaging of one or more cancers in a subject, where the imaging of the cancer provides information relating to its location, severity, and the like, so that a prognosis or possible course or outcome of the disease can be made.

[096] As used in this document, the term “resolution” in relation to an image refers more specifically to “spatial resolution” and refers to the distance between measurements. With respect to images obtained according to the methods disclosed in this document, higher resolution images have more detail. In higher resolution images, the distance between independent measurements is smaller than in lower resolution images. More specifically, the term “spatial resolution” in PET imaging refers to the differentiation of two objects. The generation of PET images that allows for higher resolution imaging means that two closer objects can be differentiated, while the same objects under lower resolution conditions may not result in differentiation.

[097] Resolution in PET image generation can be compared by quantifying and comparing values, such as a standardized uptake value (SUV). Different statistical measures of the SUV can also be determined, for example, the mean (SUVmean), the median, the maximum (SUVmax) and the like. Petition 870260082387, dated 08 / 14 / 2026, page 41 / 101 35 / 47

[098] As used in this document, the term “tumor-to-background ratio” (TTBR) is the ratio between the radiation uptake in a tumor or cancer-associated lesion and the remaining background radiation after administration of the radiotracer. For example, TTBR can be defined as the ratio between the radiation uptake in a region of interest and the radiation in a suitable background region.

[099] In certain modalities, the TTBR of a tumor or lesion may be greater than approximately 40, approximately 45, approximately 50, approximately 55, approximately 60, approximately 65, approximately 70, approximately 75, approximately 80, approximately 85, approximately 90, approximately 95, approximately 100, approximately 105, approximately 110, approximately 115, approximately 120, approximately 125, approximately 130, approximately 135, approximately 145, or approximately 150. In some modalities, the TTBR may be in a range between two of the values ​​mentioned above. In some disciplines, the TTBR ranges from approximately 40 to approximately 150. In some disciplines, the TTBR ranges from approximately 40 to approximately 140. In some disciplines, the TTBR ranges from approximately 40 to approximately 130. In some disciplines, the TTBR ranges from approximately 40 to approximately 120. In some disciplines, the TTBR ranges from approximately 40 to approximately 110. In some disciplines, the TTBR ranges from approximately 40 to approximately 100.In some disciplines, the TTBR ranges between approximately 40 and approximately 90. In some disciplines, the TTBR ranges between approximately 40 and approximately 80. In some disciplines, the TTBR ranges between approximately 40 and approximately 70.

[0100] As used in this document, the term “primary cancer” refers to a cancer that is the original tumor or the first tumor present in the patient. In certain modalities of the methods disclosed in this document, the cancer is a primary cancer. In other modalities, the cancer is a primary cancer and is prostate cancer. In some modalities, there may be more than one primary cancer, one of which is prostate cancer. Petition 870260082387, dated 08 / 14 / 2026, page 42 / 101 36 / 47

[0101] As used in this document, the term “secondary cancer” refers to a cancer derived from cells of the primary cancer that have spread to a new location, that is, where the primary cancer has metastasized. When metastasis occurs and forms a secondary cancer, this secondary cancer is the same type of cancer as the primary cancer. In certain modalities, the secondary cancer is prostate cancer.

[0102] When cancer metastasizes, cells from the primary cancer leave the primary site, spread to a new location, and form a new tumor at the new site. In certain modalities, the new site of the secondary cancer is a lymph node. Lymph nodes are part of the lymphatic system and are involved in draining lymphatic fluid from organs and other parts of the body. Because lymph nodes are found throughout the body and act as a passageway for the bloodstream and circulatory system, cells leaving a primary tumor site typically come into contact with a lymph node first. This means that secondary cancers are often found in lymph nodes and lymphatic tissue.

[0103] In certain embodiments, the secondary cancer is located in a site other than the prostate. In some embodiments of the present invention, the secondary cancer is found in a lymph node. In other embodiments, the secondary cancer is found in the bone. In other embodiments, the secondary cancer is found in the bladder. In other embodiments, the secondary cancer is found in the lungs. In other embodiments, the secondary cancer is found in the liver.

[0104] As used in this document, the “TNM staging system” refers to a specific framework for describing and classifying the stages of a cancer (see Table 1). The TNM system takes into account information relating to the primary tumor (T), the number of nearby lymph nodes with cancer (N), and whether the cancer has metastasized (M) and spread from the primary tumor to other parts of the body. Petition 870260082387, dated 08 / 14 / 2026, page 43 / 101 37 / 47 Table 1 TNM Staging System T - Size and extent of the primary tumor TX The primary tumor cannot be measured T0 The primary tumor cannot be found T1, T2, T3, T4 Refers to the size and / or extent of the primary tumor, i.e., the higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. The Ts can be further divided to provide more detail, such as T3a and T3b N - Number of regional lymph nodes with cancer NX Cancer in nearby lymph nodes cannot be measured N0 No cancer in nearby lymph nodes N1, N2, N3 Refers to the number and location of lymph nodes containing cancer, i.e., the higher the number after the N, the more lymph nodes contain cancer M - Extent of distant metastasis MX Metastasis cannot be measured M0 Cancer has not spread to other parts of the body M1 Cancer has spread to other parts of the body

[0105] As used in this document, the “Gleason Score” refers to a tumor staging system used to classify prostate cancer in a patient. Cancer cells fall into 5 distinct patterns as they change from normal prostate cells to tumor cells and are subsequently classified on a scale of 1 to 5. The Gleason score takes into account the types of cells identified by histopathology present in a patient's biopsy sample. A first Gleason grade is assigned to the most predominant cell pattern in the sample, and a second Gleason grade is assigned to the second most predominant pattern. The two grades are then added together to obtain the Gleason score, which theoretically ranges from 2 to 10; however, pathologists typically assign scores between 6 and 10.

[0106] As used in this document, the term “ISUP Grade” refers to the grade assigned to prostate cancer according to the guidelines approved by the International Society of Urological Pathology (ISUP) (see Table 2). The ISUP grade is Petition 870260082387, dated 08 / 14 / 2026, p. 44 / 101 38 / 47 based on the Gleason score, as described above, meaning the ISUP grade is also based on a biopsy sample taken from the patient. Table 2 ISUP Grade Gleason Score Definition Grade 1 2 to 6 Only distinct and well-formed individual glands Grade 2 3 + 4 = 7 Predominantly well-formed glands with a minor component of malformed / fused / cribriform glands Grade 3 4 + 3 = 7 Predominantly malformed / fused / cribriform glands with a minor component of well-formed glands Grade 4 4 ​​+ 4 = 8 Only malformed / fused / cribriform glands 3 + 5 = 8 Predominantly well-formed glands and a minor component without glands (or with necrosis) 5 + 3 = 8 Predominantly without glands (or with necrosis) and a minor component of well-formed glands Grade 5 9 to 10 Absence of gland formation (or with necrosis) with or without malformed / fused / cribriform glands

[0107] As used in this document, the term “prostate-specific antigen” (PSA) refers to a glycoprotein enzyme that is secreted by the epithelial cells of the prostate gland. Although PSA is produced by both normal and malignant prostate cells, PSA levels are generally elevated in individuals with prostate cancer. In certain modalities, a subject’s PSA level may be between approximately 4 ng / mL and approximately 10 ng / mL. In other modalities, a subject’s PSA level may be less than approximately 4 ng / mL. In other modalities, a subject’s PSA level may be greater than approximately 10 ng / mL. Although an elevated PSA level generally indicates that a patient has prostate cancer, some patients with PSA levels below approximately 4 ng / mL have prostate cancer, while other patients with higher levels between approximately 4 ng / mL and approximately 10 ng / mL Petition 870260082387, dated 08 / 14 / 2026, page 45 / 101 39 out of 47 do not have prostate cancer. Determining a subject's PSA level can be used in conjunction with other techniques, such as PET imaging, CT imaging, and similar methods, as disclosed in this document, to arrive at a diagnosis of prostate cancer.

[0108] As used in this document, the term “biochemical recurrence” in relation to prostate cancer refers to suspected prostate cancer recurrence based on elevated PSA levels following radical prostatectomy or radiotherapy, cryotherapy, or brachytherapy. In certain modalities, biochemical recurrence of prostate cancer after radical prostatectomy is characterized by detectable or rising PSA levels that are > 0.2 ng / mL with a confirmatory PSA > 0.2 ng / mL (as recommended by the American Urological Association). In other modalities, biochemical recurrence of prostate cancer after radiotherapy, cryotherapy, or brachytherapy is characterized by an increase in PSA level that is elevated by > 2 ng / mL above the nadir (according to the American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).

[0109] The term “subject,” as used in this document, refers to mammals and includes humans, primates, farm animals (e.g., sheep, pigs, cattle, horses, donkeys), laboratory test animals (e.g., mice, rabbits, rats, guinea pigs), performance and show animals (e.g., horses, cattle, dogs, cats), companion animals (e.g., dogs, cats), and wild animals in captivity. Preferably, the mammal is a human or a laboratory test animal. Even more preferably, the mammal is a human.

[0110] In certain modalities, the subject is a male patient.

[0111] However, compounds are normally used in the form of pharmaceutical compositions that are formulated depending on the desired route of administration. The compositions are prepared in well-defined ways. Petition 870260082387, dated 08 / 14 / 2026, page 46 / 101 40 / 47 known in the art.

[0112] In other embodiments, the invention provides a pharmaceutical package or kit comprising one or more containers filled with one or more of the ingredients of the pharmaceutical compositions of the invention. Such a package or kit may contain at least one container with a single dose of the agent(s). Conveniently, in the kits, the single doses may be provided in sterile vials so that the clinician can use the vials directly, where the vials will have the desired quantity and concentration of the compound and the radionucleotide which can be mixed before use. Associated with such container(s) may be various written materials, such as instructions for use, or a warning in the form prescribed by a government agency regulating the manufacture, use or sale of pharmaceuticals, imaging agents or biological products, such warning reflecting the agency's approval of the manufacture, use or sale for human administration.

[0113] The compound of Formula (I) complexed with 64Cu is provided as a composition for parenteral injection and may comprise pharmaceutically acceptable sterile aqueous or non-aqueous solutions, dispersions, suspensions or emulsions, as well as sterile powders for reconstitution into sterile injectable solutions or dispersions immediately before use. Examples of suitable aqueous and non-aqueous carriers, diluents, solvents or vehicles include water, ethanol, polyols (such as glycerol, propylene glycol, polyethylene glycol and the like) and suitable mixtures thereof, vegetable oils (such as olive oil) and injectable organic esters such as ethyl oleate. Adequate flowability may be maintained, for example, by the use of coating materials such as lecithin, by maintaining the required particle size in the case of dispersions and by the use of surfactants.

[0114] These compositions may also contain adjuvants, such as preservatives, humectants, emulsifying agents and dispersing agents. A Petition 870260082387, dated 08 / 14 / 2026, page 47 / 101 41 / 47 Prevention of microorganism action can be ensured by the inclusion of various antibacterial and antifungal agents, for example, parabens, chlorobutanol, phenolsorbic acid and the like. It may also be desirable to include isotonic agents, such as sugars, sodium chloride and the like. Prolonged absorption of the injectable pharmaceutical form can be achieved by the inclusion of agents that retard absorption, such as aluminum monostearate and gelatin. Other additives may include formulation stabilizers, such as sodium gentisate, sodium ascorbate and the like.

[0115] Injectable formulations can be sterilized, for example, by filtration through a bacteria-retention filter or by incorporating sterilizing agents in the form of sterile solid compositions that can be dissolved or dispersed in sterile water or other sterile injectable medium immediately before use.

[0116] In the methods disclosed in this document, the compound of Formula (I) complexed with 64Cu is administered as an aqueous formulation, wherein the formulation is administered parenterally, preferably intravenously. In certain embodiments, the compound of Formula (I) complexed with 64Cu is administered intravenously as a bolus or infusion. In some embodiments, the compound of Formula (I) complexed with 64Cu is administered as a single intravenous bolus injection.

[0117] Reference in this descriptive report to any prior publication (or information derived therefrom), or to any known material, is not, and should not be considered as, an acknowledgment or admission or any form of suggestion that such prior publication (or information derived therefrom) or known material forms part of the common general knowledge in the field of activity to which this descriptive report refers.

[0118] Those skilled in the art will realize that the invention described in this document is susceptible to variations and modifications other than those Petition 870260082387, dated 08 / 14 / 2026, p. 48 / 101 42 / 47 specifically described. It should be understood that the invention includes all variations and modifications that fall within its spirit and scope. The invention also includes all steps, features, compositions and compounds that refer to or are indicated in this descriptive report, individually or collectively, and any and all combinations of two or more steps or features. Examples

[0119] The following examples are illustrative of disclosure and should not be interpreted as limiting in any way the overall nature of the disclosure of the description throughout this descriptive report.

[0120] The compound of Formula (I) complexed with 64Cu is supplied to clinical sites as a sterile, ready-to-use formulation for intravenous injection. The final formulation of the compound of Formula (I) complexed with 64Cu contains sodium phosphate buffer, sodium gentisate, and sodium ascorbate and has a final pH in the range of 4 to 8. 68Ga-PSMA-11 is produced at each clinical center as needed. Example 1 - PET imaging of patients

[0121] Patients with untreated, histopathologically proven, intermediate- to high-risk PC, planned for radical prostatectomy, underwent PET / CT with 68Ga-PSMA-11 according to institutional practice and were subsequently allocated to 1 of 3 dose cohorts (1:1:3) to receive 100 MBq, 150 MBq, or 200 MBq of 64Cu-SAR-bisPSMA, respectively. The specified dose of 64CuSAR-bisPSMA was administered to each patient as a single IV bolus injection. Alternatively, a specified dose of 68Ga-PSMA-11 or 18F-DCFPyL was administered to the patient. A PET / CT scan was performed 3 hours (±1 hour) after the injection of 64Cu-SAR-bisPSMA, 68Ga-PSMA-11, or 18F-DCFPyL. PET / CT scans at other times after the compound injection were acquired as needed. Example 2 - Acquisition parameters for PET imaging Petition 870260082387, dated 08 / 14 / 2026, page 49 / 101 43 / 47

[0122] Patients were examined using the standard clinical protocol for whole-body PET / CT acquisition defined for each clinical site and in accordance with the Image Acquisition Manual, which contains details of examination acquisition, processing parameters, and quality assurance procedures. The same CT scanner was used at each visit. Typical image acquisition parameters are below (see Table 3): Table 3 PARAMETERS* VALUES CT Energy 110 to 130 kVp CT Effective mAs 50 to 150 mAs (with automatic exposure control) CT Slice Thickness Acquisition and Reconstruction SOC (2 to 3 mm gapless) CT Pitch 0.8 to 1 CT Kernel Smoothly Medium Whole Body in Position on PET Bed 6 to 8 PET Time per Position on Bed 180 seconds PET Reconstruction Images • CT-based Attenuation Correction (AC) • Dispersion Correction (SC) • Resolution Recovery • ToF PET Reconstruction Parameters • Iterations and Subsets: Vendor-specific • Matrix Size as for standard WB scans • Post-Reconstruction Filter: Gaussian, FWHM 5 to 8 mm Example 3 - PET image analysis

[0123] Two independent, blinded central readers assessed the detection of primary PC on 200 MBq 64Cu-SAR-bisPSMA PET / CTs as the primary outcome. To compare lesion intensity on 68Ga-PSMA-11 and 64Cu-SAR-bisPSMA PET / CTs, both readers determined SUVs (SUVmax, SUVmean) and Petition 870260082387, dated 08 / 14 / 2026, pp. 50 / 101 44 / 47 the tumor / fundus ratio (ratio between lesion SUVmax and fundus SUVmean) in up to 5 concordant lesions between 68Ga-PSMA-11 and 64Cu-SAR-bisPSMA PET / CT as an exploratory endpoint.

[0124] Tables 4 and 5 below compare the SUV parameters obtained from PET / CT images after administration of 68Ga-PSMA-11 and a 200 MBq dose of 64Cu-SAR-bisPSMA from each reader. Imaging with 64Cu-SAR-bisPSMA showed consistently higher SUVmax and SUVmean values ​​when compared to images obtained with 68Ga-PSMA-11. Table 4 Parameter Imaging N Mean SD Median Minimum Maximum Median Difference p-value*# SUVmax 64Cu 17 40.28 31.54 31.40 8 100 14.85 p < 68Ga 17 15.80 13.98 10.08 2.7 48.8 0.001 SUVmean 64Cu 17 27.25 21.71 21.76 5.5 69.9 9.64 p = 68Ga 17 10.57 9.57 6.58 1.8 33.3 0.0047 TTBR 64Cu 17 77.25 68.33 49.07 10.3 227.3 27.15 p = 68Ga 17 35.90 29.42 21.91 9.6 106.4 0.0015 TTBR = Tumor-to-fundus ratio. * Comparison of imaging methods performed with the two-sided Wilcoxon signed-rank test; # Violation of the normality assumption confirmed with the Shapiro-Wilk test for normality (p < 0.05). The mean of the lesions was calculated for each participant, so that each participant contributed once to the summary statistics. Table 5 Parameters Imaging N Mean SD Median Minimum Maximum Median Difference p-value SUVmax 64Cu 13 47.37 33.58 41.00 6.1 100 27.03 p < 68Ga 13 18.19 15.29 14.58 2.7 48.8 0.001 SUVmedia 64Cu 13 31.78 23.35 28.07 4.4 69.9 18.44 p < 68Ga 13 12.21 10.40 9.79 1.8 33.1 0.001 TTBR 64Cu 13 86.40 69.51 76.34 6.7 212.8 45.37 p < 68Ga 13 36.96 31.75 23.90 5 95.6 0.001 TTBR = Tumor-to-fundus ratio. * Comparison of imaging methods performed using the two-sided Wilcoxon signed-rank test; # Violation of the normality assumption confirmed with the Shapiro-Wilk test for normality (p < 0.05). The mean of the lesions was calculated for each participant, so that each participant contributed once to the summary statistics.

[0125] Tables 6 and 7 below compare SUV parameters obtained from PET / CT images after administration of 68Ga-PSMA-11 (200 MBq) and 64Cu-SAR. Petition 870260082387, dated 08 / 14 / 2026, page 51 / 101 45 / 47 bisPSMA (200 MBq) per reader. Table 6 Parameter Imaging N Mean SD Median Minimum Maximum Median Difference p-value*# SUVmax 64Cu 28 41.66 30.27 30.26 8.00 100.00 14.23 p < 68Ga 28 17.45 13.71 13.53 2.70 55.10 0.001 SUVmean 64Cu 28 27.41 20.93 21.20 5.40 69.90 9.26 p < 68Ga 28 11.71 9.37 9.12 1.80 37.60 0.001 TTBR 64Cu 28 83.38 72.13 53.55 10.30 294.10 27.94 p < 68Ga 28 40.04 31.54 24.29 9.60 134.40 0.001 TTBR = Tumor-to-fundus ratio. * Comparison of imaging methods performed with the two-sided Wilcoxon signed-rank test; # Violation of the normality assumption confirmed with the Shapiro-Wilk test for normality (p < 0.05). The mean of the lesions was calculated for each participant, so that each participant contributed once to the summary statistics. Table 7 Parameters Imaging N Mean SD Median Minimum Maximum Median Difference p-value SUVmax 64Cu 16 49.73 34.53 41.66 6.1 100 27.99 p < 68Ga 16 19.82 16.93 14.93 2.7 55.1 0.001 SUVmedia 64Cu 16 33.24 23.75 28.4 4.4 69.9 18.78 p < 68Ga 16 13.29 11.56 9.94 1.8 37.6 0.001 TTBR 64Cu 16 93.86 76.09 78.37 6.7 243.9 46.93 p < 68Ga 16 41.61 35.53 24.69 5 112.4 0.001 TTBR = Tumor-to-fundus ratio. * Comparison of imaging methods performed with the two-sided Wilcoxon signed-rank test; # Violation of the normality assumption confirmed with the Shapiro-Wilk test for normality (p < 0.05). The mean of the lesions was calculated for each participant, so that each participant contributes once to the summary statistics.

[0126] Table 8 compares the number of positive, negative, and indeterminate images evaluated by each reader. Reader 1 detected primary prostate cancer in 100% of patients who were administered 200 MBq of 64CuSar-bisPSMA, while Reader 2 detected it in 85.7% of patients. This contrasts with 77.8% and 83.3%, respectively, when 68Ga-PSMA-11 was administered. Table 8 Reader 64Cu-SAR-bisPSMA PET 68Ga-PSMA-11 PET Petition 870260082387, dated 08 / 14 / 2026, page 52 / 101 46 / 47 Positive Negative Undetermined Positive Negative Undetermined 1 18 / 18 0 / 18 0 / 18 14 / 18 0 / 18 4 / 18 2 12 / 14* 0 / 14* 2 / 14* 15 / 18 0 / 18 3 / 18 *Four exams were excluded by the reader, who considered them not valuable.

[0127] The resulting True Positive Rate (TPR) and False Negative Rate (FNR) were similar for o64Cu-Sar-bisPSMA and o68Ga-PSMA-11, as shown in Table 9. Table 9 Reader 64Cu-SAR-bisPSMA PET 68Ga-PSMA-11 PET % TPR (95 % CI) % FNR (95 % CI) % TPR (95 % CI) % FNR1 (95 % CI) p2 value 1 100.0 (81.5; 100.0) 0.0 (0.0; 18.5) 77.8 (52.4; 93.6) 22.2 (6.4; 47.6) 0.13 2 85.7 (57.2; 98.2) 14.3 (1.8; 42.8) 83.3 (58.6; 96.4) 16.7 (3.6; 41.4) 1.0 1Indeterminate results were analyzed as negative. 2McNemar's chi-square test with continuity correction.

[0128] The number of lesions detected by each reader was evaluated using 64Cu-Sar-bisPSMA or 68Ga-PSMA-11 imaging. These results are shown in Table 10. For both readers, the total number of lesions, the mean, and the median number of lesions detected as a result of 64Cu-Sar-bisPSMA imaging were higher compared to 68Ga-PSMA-11 imaging, with the difference between these values ​​being statistically significant. Table 10 PET Reader Total number of lesions detected (all participants) Average number of lesions per participant Standard deviation (SD) Average number of lesions per participant Mean difference Median difference p-value** All cohorts Reader 1 (N=29) 64Cu 63 2.2 1.2 2 0.41 0.0 0.1005 68Ga 51 1.8 1.3 1 Petition 870260082387, dated 08 / 14 / 2026, page 53 / 101 47 / 47 Reader 2 (N=17*) 64Cu 34 2 1.4 4 0.52 0.0 0.0748 68Ga 25 1.5 0.9 1 200 MBq Cohort Reader 1 (N=29) 64Cu 41 2.3 1.4 2 0.28 0.0 0.442 7 68Ga 36 2.0 1.1 1 Reader 2 (N=17*) 64Cu 31 2.2 1.5 2 0.64 0.0 0.0749 68Ga 22 1.6 1.0 1 **Comparison of imaging methods performed using the two-sided Wilcoxon signed-rank test. Violation of the normality assumption confirmed with the Shapiro-Wilk normality test (p < 0.05). Only participants who had evaluable examinations for both imaging modalities were included in the analysis. The difference between imaging modalities is the number of lesions detected with 64Cu-SAR-bisPSMA PET / CT compared to 68Ga-PSMA-11 PET / CT in a participant (i.e., 64Cu - 68Ga). A negative value indicates more lesions detected with 68Ga-PSMA-11 PET / CT than with 64Cu-SAR-bisPSMA PET / CT. The study was not powered to detect differences at the individual level.**

[0129] As seen in Table 11, the specificity in detection on all PET image readers was high, regardless of whether the images were obtained on the day of administration or the day after administration of 64Cu-SarbisPSMA. The relative decrease in specificity with imaging the day after administration relates to the challenges in obtaining the reference standard for the larger number of lesions identified, where biopsy of all lesions was not feasible, and due to the low sensitivity of imaging with existing protocols. Table 11 Day 0 Interval between readers in % (95% CI) Day 1 Interval between readers in % (95% CI) CDR (patient level) 21.4-28.6 (10.3-44.6) 28.6-38.1 (15.7-54.4) DR (patient level) 44-58 (30-71) 58-80 (43.2-90) PPV (region level) 39.1-44.8 (19.7-64.3) 32.7-43.3 (20.3-62.6) Specificity (pelvic LNs) 93.8-96.9 (79.2-99.9) 81.3-87.9 (63.6-96.6) CDR: Correct detection rate. DR: Detection rate. PPV: Positive predictive value. LNs: lymph nodes. IC: confidence interval. Petition 870260082387, dated 08 / 14 / 2026, p. 54 / 101

Claims

1 / 23 CLAIMS 1. A method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of about 100 MBq to about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtaining an image of the subject by means of PET imaging at least about 8 hours after administration of the compound of Formula (I).

2. Method according to claim 1, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

3. Method, according to claim 1 or 2, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

4. Method, according to any one of claims 1 to 3, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

5. Method, according to any one of claims 1 to 4, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I). Petition 870250071547, dated 08 / 13 / 2025, p. 7 / 30 2 / 23 6. Method, according to any one of claims 1 to 5, CHARACTERIZED in that the PSMA receptor-associated cancer is a prostate cancer.

7. Method according to claim 6, characterized in that prostate cancer is associated with biochemical recurrence.

8. Method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of approximately 100 MBq to approximately 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; and Formula (I) ii) obtaining an image of the subject by means of PET imaging; and iii) determining the tumor-to-fund ratio (TTBR) of one or more lesions detected by means of imaging in step ii); wherein the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in a subject is greater than approximately 40. >40 as minimum, 150 as maximum.

9. Method according to claim 8, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

10. Method according to claim 8 or 9, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

11. Method, according to any one of claims 8 to 10, CHARACTERIZED in that the subject's imaging by means of Petition 870250071547, dated 08 / 13 / 2025, page 8 / 30 3 / 23 PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

12. Method, according to any one of claims 8 to 11, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

13. Method, according to any one of claims 8 to 12, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

14. Method, according to any one of claims 8 to 13, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70 or between about 40 and about 60.

15. Method, according to any one of claims 8 to 14, CHARACTERIZED in that the cancer associated with PSMA receptor overexpression is prostate cancer.

16. Method according to claim 15, characterized in that prostate cancer is associated with biochemical recurrence.

17. Method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose between about 100 MBq and about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Petition 870250071547, dated 13 / 08 / 2025, p. 9 / 30 4 / 23 Formula (I) ii) obtaining an image of the subject by means of PET imaging at least about 8 hours after administration of the compound of Formula (I); iii) determining the tumor-to-fund ratio (TTBR) of a lesion visualized by imaging in step ii); wherein the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in the subject is greater than about 40.

18. Method according to claim 17, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

19. Method according to claim 17 or 18, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 8 hours, approximately 10 hours, approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

20. Method, according to any one of claims 17 to 19, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

21. Method, according to any one of claims 17 to 20, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70 or between about 40 and about 60.

22. Method, according to any one of claims 17 to 21, CHARACTERIZED in that the cancer associated with PSMA receptor overexpression is prostate cancer.

23. Method according to claim 22, CHARACTERIZED in that prostate cancer is associated with biochemical recurrence.

24. Method for imaging a lesion in a cancer associated with overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose between about 100 MBq and about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtaining an image of the subject by means of PET imaging; iii) determining the tumor-to-fund ratio (TTBR) of one or more lesions detected by means of imaging in step ii); wherein the lesion has a characteristic tumor-to-fund ratio (TTBR) of more than about 40.

25. Method according to claim 24, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

26. Method according to claim 24 or 25, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

27. Method, according to any of claims 24 to 26, Petition 870250071547, dated 08 / 13 / 2025, page 11 / 30 6 / 23 CHARACTERIZED by the fact that the subject's imaging by means of PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

28. Method, according to any one of claims 24 to 27, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

29. Method, according to any one of claims 24 to 28, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

30. Method, according to any one of claims 24 to 29, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 to 150, between about 40 to 140, between about 40 to 130, between about 40 to 120, between about 40 to 110, between about 40 to 100, between about 40 to 90, between about 40 to 80, between about 40 to 70 or between about 40 to 60.

31. Method, according to any one of claims 24 to 30, CHARACTERIZED in that the cancer is prostate cancer.

32. Method according to claim 31, CHARACTERIZED in that prostate cancer is associated with biochemical recurrence.

33. Method for imaging a lesion in a cancer associated with overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose between about 100 MBq and about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Petition 870250071547, dated 13 / 08 / 2025, p. 12 / 30 7 / 23 Formula (I) ii) obtaining an image of the subject by means of PET imaging at least about 8 hours after administration of the compound of Formula (I); iii) determining the tumor-to-fund ratio (TTBR) of one or more lesions detected by imaging in step ii); wherein the lesion has a characteristic tumor-to-fund ratio (TTBR) of more than about 40.

34. Method according to claim 33, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

35. Method according to claim 33 or 34, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 8 hours, approximately 10 hours, approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

36. Method, according to any one of claims 33 to 35, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

37. Method, according to any one of claims 33 to 36, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70 or between about 40 and about 60.

38. Method, according to any one of claims 33 to 37, CHARACTERIZED in that the TTBR of the lesion in a cancer associated with the overexpression of a PSMA receptor is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

39. Method, according to any one of claims 33 to 38, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70, or between about 40 and about 60.

40. Method, according to any one of claims 33 to 39, CHARACTERIZED in that the cancer associated with PSMA receptor overexpression is prostate cancer.

41. Method according to claim 40, characterized in that prostate cancer is associated with biochemical recurrence.

42. Method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of about 100 to about 300 MBq of a compound of Formula (I) or of a salt thereof complexed with 64Cu; and ii) obtaining an image of the subject by means of PET imaging at least once between about 30 minutes and about 36 hours after administration of the compound of Formula (I); Petition 870250071547, dated 13 / 08 / 2025, p. 14 / 30 9 / 23 Formula (I) in which the imaging of the cancer has a higher resolution compared to 68Ga-PSMA-11 administered under standard treatment conditions.

43. Method for the detection and / or diagnosis of a cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of about 100 to about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtaining an image of the subject by means of PET imaging at least about 8 hours after administration of the compound of Formula (I); wherein the imaging of the cancer has a higher resolution compared to 68Ga-PSMA-11 administered under standard treatment conditions.

44. Method according to claim 42 or 43, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

45. Method according to claim 44, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

46. ​​Method, according to any of claims 42 to 45, Petition 870250071547, dated 08 / 13 / 2025, page 15 / 30 10 / 23 CHARACTERIZED by the fact that the subject's imaging by means of PET imaging occurs within a period of approximately 10 hours after administration of the compound of Formula (I).

47. Method, according to any one of claims 42 to 46, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

48. Method, according to any one of claims 42 to 47, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

49. Method, according to any one of claims 42 to 48, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70, or between about 40 and about 60.

50. Method, according to any one of claims 42 to 49, CHARACTERIZED in that the cancer is prostate cancer.

51. Method according to claim 50, CHARACTERIZED in that prostate cancer is associated with biochemical recurrence.

52. Method for the detection and / or diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose between about 100 MBq and about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; ii) obtaining an image of the subject by means of PET imaging at least about 8 hours after administration of the compound of Formula (I).

53. Method according to claim 52, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

54. Method according to claim 52 or 53, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 8 hours after administration of the compound of Formula (I).

55. Method, according to any one of claims 52 to 54, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 10 hours, approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

56. Method, according to any one of claims 52 to 55, CHARACTERIZED in that the PSMA receptor-associated cancer is a prostate cancer.

57. Method according to claim 56, CHARACTERIZED in that prostate cancer is associated with biochemical recurrence.

58. Method for the detection and diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: Petition 870250071547, dated 13 / 08 / 2025, page 17 / 30 12 / 23 i) administering to the subject a dose of about 100 MBq to about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtaining an image of the subject by means of PET imaging; and iii) determining the tumor-to-fund ratio (TTBR) of a lesion visualized by means of imaging; wherein the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in a subject, as detected by means of imaging in step ii), is greater than about 40.

59. Method according to claim 58, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

60. Method according to claim 58 or 59, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

61. Method, according to any one of claims 58 to 60, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

62. Method, according to any one of claims 58 to 61, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I). Petition 870250071547, dated 08 / 13 / 2025, p. 18 / 30 13 / 23 63. Method, according to any one of claims 58 to 62, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

64. Method, according to any one of claims 58 to 63, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70, or between about 40 and about 60.

65. Method, according to any one of claims 58 to 64, CHARACTERIZED in that the cancer is prostate cancer.

66. Method according to claim 65, characterized in that prostate cancer is associated with biochemical recurrence.

67. Method for the detection and / or diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED by the fact that it comprises: i) administering to the subject a dose between approximately 100 MBq and approximately 300 MBq of a compound of Formula (I) or of a salt thereof complexed with 64Cu; Formula (I) ii) obtaining an image of the subject by means of PET imaging at least approximately 8 hours after administration of the compound of Formula (I); iii) determining the tumor-to-fund ratio (TTBR) of a lesion visualized by imaging means; where the tumor-to-fundus ratio (TTBR) of a cancer-associated lesion in a subject, as detected by imaging in step ii), is greater than approximately 40.

68. Method according to claim 67, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

69. Method according to claim 67 or 68, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 10 hours, approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

70. Method, according to any one of claims 67 to 69, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

71. Method, according to any one of claims 67 to 70, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70, or between about 40 and about 60.

72. Method, according to any one of claims 67 to 71, CHARACTERIZED in that the cancer is prostate cancer.

73. According to another aspect, the present invention comprises a method for the detection and diagnosis of a secondary cancer related to a primary cancer associated with the overexpression of a PSMA receptor in a subject in need thereof, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of about 100 to about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; ii) obtaining an image of the subject by means of PET imaging at least once between about 30 minutes and about 36 hours after administration of the compound of Formula (I); and iii) diagnose secondary cancer based on one or more images obtained in step ii), where the cancer image is at a higher resolution compared to 68Ga-PSMA-11 administered under standard treatment conditions.

74. Method according to claim 73, CHARACTERIZED in that the dose of the compound of Formula (I) or of a pharmaceutically acceptable salt thereof complexed with 64Cu is about 200 MBq.

75. Method according to claim 73 or 74, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 10 hours, approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

76. Method, according to any one of claims 73 to 75, CHARACTERIZED in that the cancer is prostate cancer.

77. Method, according to any one of claims 73 to 76, CHARACTERIZED in that the secondary cancer is in a lymph node, bone, bladder, lung, or liver. Petition 870250071547, dated 08 / 13 / 2025, pp. 21 / 30 16 / 23 78. Method for determining the TNM stage of prostate cancer in a subject, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of about 100 MBq to about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; Formula (I) ii) obtaining an image of the subject by means of PET imaging; and iii) determining the TNM stage of the cancer based on one or more images obtained in step ii) and the ISUP grade of the tumor; wherein the ISUP grade of the tumor is determined prior to steps i) to iii).

79. Method according to claim 78, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

80. Method, according to any one of claims 78 to 79, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

81. Method, according to any one of claims 78 to 80, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

82. Method, according to any one of claims 78 to 81, CHARACTERIZED in that imaging of the subject by means of PET imaging identifies one or more lesions associated with prostate cancer. Petition 870250071547, dated 08 / 13 / 2025, pp. 22 / 30 17 / 23 83. Method, according to any one of claims 78 to 82, CHARACTERIZED in that the method further comprises the step of determining the tumor-to-fund ratio (TTBR) of a lesion visualized by imaging, wherein the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in a subject, as detected by imaging in step ii), is greater than about 40.

84. Method, according to any one of claims 78 to 83, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

85. Method, according to any one of claims 78 to 84, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70, or between about 40 and about 60.

86. Method, according to any one of claims 78 to 85, CHARACTERIZED in that the ISUP grade of the tumor is Grade 1, Grade 2, Grade 3, Grade 4 or Grade 5.

87. Method, according to any one of claims 78 to 85, CHARACTERIZED in that the ISUP grade of the tumor is determined by calculating the Gleason score.

88. Method according to claim 87, CHARACTERIZED in that the Gleason score is 6, 7, 8, 9 or 10.

89. Method, according to any one of claims 77 to 88, CHARACTERIZED in that the TNM stage of prostate cancer is selected from one or more of TX, T0, T1, T2, T3, T4, NX, N0, N1, N2, N3, MX, M0 or M1.

90. Method for reassessing the TNM stage of prostate cancer in a subject, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of between about 100 MBq and about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; ii) obtaining an image of the subject by means of PET imaging; iii) first determining the stage of the prostate cancer based on one or more images obtained in step ii); and iv) repeating steps i) and ii) and determining the stage of the prostate cancer based on one or more images obtained by imaging the subject after the second administration of the compound of Formula (I) according to step i).

91. Method according to claim 90, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

92. Method according to claim 90 or 91, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

93. Method, according to any one of claims 90 to 92, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

94. Method, according to any of claims 90 to 93, Petition 870250071547, dated 08 / 13 / 2025, p. 24 / 30 19 / 23 CHARACTERIZED by the fact that imaging of the subject by means of PET imaging identifies one or more lesions associated with prostate cancer.

95. Method, according to any one of claims 90 to 94, CHARACTERIZED in that the method further comprises the step of determining the tumor-to-fund ratio (TTBR) of a lesion visualized by imaging, wherein the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in a subject, as detected by imaging in step ii), is greater than about 40.

96. Method, according to any one of claims 90 to 95, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

97. Method, according to any one of claims 90 to 96, CHARACTERIZED in that the TTBR of a cancer-associated lesion is between about 40 and about 150, between about 40 and about 140, between about 40 and about 130, between about 40 and about 120, between about 40 and about 110, between about 40 and about 100, between about 40 and about 90, between about 40 and about 80, between about 40 and about 70, or between about 40 and about 60.

98. Method for determining the progression of cancer in a subject, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose of between about 100 MBq and about 300 MBq of a compound of Formula (I) or of a salt thereof complexed with 64Cu; ii) obtaining an image of the subject by means of PET imaging; iii) first determining the TNM stage of prostate cancer based on one or more images obtained in step ii); and iv) repeating steps i) and ii) and determining the TNM stage of prostate cancer based on one or more images obtained by imaging the subject after the second administration of the compound of Formula (I) according to step i).

99. Method according to claim 98, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 8 hours after administration of the compound of Formula (I).

100. Method according to claim 98 or 99, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

101. Method, according to any one of claims 98 to 100, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

102. Method, according to any one of claims 98 to 101, CHARACTERIZED in that imaging of the subject by means of PET imaging identifies one or more lesions associated with prostate cancer.

103. Method, according to any one of claims 98 to 102, CHARACTERIZED in that the method further comprises the step of determining the tumor-to-fund ratio (TTBR) of a lesion visualized by imaging, wherein the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in a subject, as detected by imaging in step ii), is greater than about 40.

104. Method, according to any one of claims 98 to 103, CHARACTERIZED in that the TTBR of a cancer-associated lesion is approximately 50, approximately 60, approximately 70, approximately 80, approximately 90, approximately 100, approximately 110, approximately 120, approximately 130, approximately 140 or approximately 150.

105. Method, according to any one of claims 98 to 104, CHARACTERIZED by the fact that the TNM stage of prostate cancer after reassessment is higher.

106. Method, according to any one of claims 98 to 104, CHARACTERIZED in that the TNM stage of prostate cancer after reassessment includes an N1, N2, or N3 stage.

107. Method, according to any one of claims 98 to 104, CHARACTERIZED by the fact that the TNM stage of prostate cancer after reassessment is lower.

108. Method, according to any one of claims 98 to 104, CHARACTERIZED in that the TNM stage of prostate cancer after reassessment includes a TO, NO, or M0 stage.

109. According to another aspect, the present invention provides a method for reassessing the TNM stage of prostate cancer in a subject, the method CHARACTERIZED in that it comprises: i) administering to the subject a dose between about 100 MBq and about 300 MBq of a compound of Formula (I) or a salt thereof complexed with 64Cu; ii) obtaining an image of the subject by means of PET imaging at least once between about 30 minutes and about 36 hours after administration of the compound of Formula (I); iii) first determining the stage of the prostate cancer based on one or more images obtained in step ii); and iv) repeat steps i) and ii) and determine the stage of prostate cancer based on one or more images after the second administration according to step i).

110. Method according to claim 109, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 8 hours after administration of the compound of Formula (I).

111. Method according to claim 109 or 110, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs approximately 10 hours after administration of the compound of Formula (I).

112. Method, according to any one of claims 109 to 111, CHARACTERIZED in that the subject's imaging by means of PET imaging occurs within a period of approximately 12 hours, approximately 16 hours, approximately 20 hours, approximately 24 hours, approximately 28 hours, approximately 32 hours, or approximately 36 hours after administration of the compound of Formula (I).

113. Method, according to any one of claims 109 to 112, CHARACTERIZED in that imaging of the subject by means of PET imaging identifies one or more lesions associated with prostate cancer.

114. Method, according to any one of claims 109 to 113, CHARACTERIZED in that the method further comprises the step of determining the tumor-to-fund ratio (TTBR) of a lesion visualized by imaging, wherein the tumor-to-fund ratio (TTBR) of a cancer-associated lesion in a subject, as detected by imaging in step ii), is greater than about 40.

115. Method, according to any one of claims 109 to 114, CHARACTERIZED in that the TTBR of a cancer-associated lesion is about 50, about 60, about 70, about 80, about 90, about 100, about 110, about 120, about 130, about 140 or about 150.

116. Method, according to any one of claims 109 to 115, CHARACTERIZED in that the TNM stage of prostate cancer after reassessment is higher.

117. Method, according to any one of claims 109 to 115, CHARACTERIZED in that the TNM stage of prostate cancer after reassessment includes an N1, N2, or N3 stage.

118. Method, according to any one of claims 109 to 115, CHARACTERIZED in that the TNM stage of prostate cancer after reassessment is lower.

119. Method, according to any one of claims 109 to 115, CHARACTERIZED in that the TNM stage of prostate cancer after reassessment includes a T0, N0, or M0 stage. Petition 870250071547, dated 08 / 13 / 2025, pp. 29 / 30

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