Validation Study of Proclarix Blood Test for Prostate Cancer Risk in Diverse US Men Aged 40 to 75 Years

What this Trial Is About

Prostate cancer is a common cause of illness and death among men worldwide, with black men facing earlier, more frequent, and aggressive forms of the disease. This study evaluates the Proclarixae blood test, designed to help identify men at risk for clinically significant prostate cancer, particularly in a diverse multi-ethnic US population. Current risk tools often lack accuracy for different ethnic groups, so this research aims to confirm Proclarixaes performance beyond European populations. Participants with elevated PSA levels between 2 and 10 ngmL, who are scheduled for a prostate biopsy, provide a blood sample before their biopsy. The blood is tested using Proclarixae, which measures two biomarkers, thrombospondin 1 and cathepsin D, combined with PSA levels and age to produce a risk score. Prostate biopsies are conducted as per usual clinical practice, and biopsy results are compared with Proclarixae scores to assess test accuracy. During the study, participants provide informed consent, blood samples, and diagnostic test results. Researchers review biopsy outcomes and compare them with Proclarixae results to evaluate its clinical accuracy. The main measure is how well Proclarixae predicts significant prostate cancer within 90 days from enrollment. Additional analysis includes how Proclarixae relates to other diagnostic tests like MRI or ultrasound. Participation lasts until biopsy results are collected, up to 90 days.

Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix