Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer

What this Trial Is About

Researchers are investigating three specific glycoprotein biomarkers—GALNT7, ST6GAL1, and GCNT1—to improve the detection of clinically significant prostate cancer. This study aims to evaluate how well these biomarkers, alone or combined with the standard PSA test, can identify prostate cancer cases that require treatment. The study focuses on men suspected of having prostate cancer or those under active surveillance, addressing the limitations of PSA testing and the need for better diagnostic tools. The study is observational and involves collecting venous blood samples from male patients attending hospital urology departments for a transperineal prostate biopsy. These blood samples will be tested using enzyme-linked immunosorbent assays (ELISA) to measure the three biomarkers and PSA levels. The diagnostic accuracy of these tests will be compared with biopsy results and multiparametric MRI findings to assess their ability to detect significant prostate cancer and to help predict tumor aggressiveness. Participants will provide blood samples before their biopsy, and researchers will access their diagnostic results to correlate biomarker levels with cancer severity. The study will assess the biomarkers’ diagnostic sensitivity and specificity, develop a combined GlycoScore algorithm, and compare it against PSA testing alone. This process involves one pre-biopsy blood draw, with data analyzed to evaluate the biomarkers’ potential clinical use. Participation involves a single blood sample and access to medical diagnosis information, with the study expected to recruit 137 male patients aged 18 years and older over about 12 months.

Investigation of Three Biomarkers for the Detection of Prostate Cancer