The invention relates to a method for the determination of a
cancer diagnostic / therapeutic biomarker
assay and
drug-targets including the following steps: (a) identification of
potential candidate protein /
peptide biomarkers and
drug-targets based on the measurement of
protein /
peptide constituent concentrations in
tissue sample proteomes as well as serum,
plasma or any other derivatives of blood, or blood itself sample proteomes derived from healthy non-human mammalian individuals as well as from cancerous non-human mammalian individuals and qualitatively selecting as
potential candidate protein /
peptide biomarkers those which show a pronounced differential behaviour between healthy and cancerous sample proteomes; (b) optional
verification of the
potential candidate protein / peptide biomarkers as identified in step (a) by quantitative
mass spectrometric measurement of the potential candidate
protein biomarkers in serum,
plasma or any other derivatives of blood, or blood itself sample proteomes derived from healthy non-human mammalian individuals as well as from cancerous non-human mammalian individuals and selecting as candidate protein / peptide biomarkers those which show a
mass-spectrometrically measurable quantitative differential behaviour between healthy and cancerous sample proteomes; (c) validation of the candidate protein / peptide biomarkers as identified in step (a), or as optionally verified in step (b), by
mass spectrometric measurement and / or
antibody-based assays such as an
Enzyme-Linked Immunosorbent
Assay (ELISA) determination of the candidate
protein biomarkers in serum,
plasma or any other derivatives of blood, or blood itself sample proteomes derived from healthy human individuals as well as from cancerous human individuals and selecting as protein / peptide biomarkers those which show a mass-spectrometrically measurable and / or
antibody-based
assay detectable differential behaviour between healthy and cancerous sample proteomes; (d) application of statistical methods to uncover single or groups of protein / peptide biomarkers as validated in step (c) as signatures for the detection of patients with
cancer. The invention furthermore relates to specific biomarker assays for the highly reliable diagnosis of
cancer, specifically of localized or non-localized
prostate cancer, using human serum, plasma or any other derivatives of blood, or blood itself.