Evaluation of GlycoScore Biomarkers Using Blood Tests to Detect Clinically Significant Prostate Cancer

What this Trial Is About

Prostate cancer is the most commonly diagnosed cancer in men worldwide and a leading cause of cancer death. This research aims to evaluate three specific glycoprotein biomarkers (GALNT7, ST6GAL1, and GCNT1) that have shown potential in detecting clinically significant prostate cancer. The study focuses on improving diagnostic accuracy compared to the current PSA test, which often leads to unnecessary biopsies due to false positives. Researchers want to find the best biomarker or combination of biomarkers to develop a more precise GlycoScore test. The study involves collecting venous blood samples from male patients suspected of having prostate cancer or those under active surveillance who are attending a hospital for a transperineal prostate biopsy. The blood will be tested using enzyme-linked immunosorbent assays (ELISA) to measure the levels of the three GlycoScore biomarkers and PSA. The study is non-interventional and prospective, with samples sent to specialized laboratories for analysis. Additional blood and urine samples may be collected for future research. Participants will provide consent before biopsy, and their final diagnosis will be accessed for comparison with biomarker results. The study will assess sensitivity and specificity of the biomarkers alone and combined with PSA, correlating findings with biopsy Gleason scores and imaging results. Researchers will monitor safety and diagnostic performance during the 12-month recruitment and study period involving 137 male patients aged 18 years and older.

Investigation of Three Biomarkers for the Detection of Prostate Cancer