This study is looking at a blood test called Proclarix to help identify the risk of aggressive prostate cancer. Proclarix combines two special markers (thrombospondin 1 and cathepsin D) with standard prostate-specific antigen (PSA) levels to give a risk score. The goal is to see how well Proclarix works in a diverse group of men in the United States compared to the results from a prostate biopsy. You might be able to join if you are a man between 40 and 75 years old and have a PSA level between 2 and 10 ng/mL. The study aims to enroll 500 participants. The main goal is to compare the Proclarix test results with your biopsy results within 90 days of joining.

Study design

This is an observational study involving up to 500 men across multiple clinics in the US. It is a single-group study, meaning all participants will receive the same diagnostic test.

What's involved

You will provide a blood sample before your scheduled prostate biopsy. Your biopsy will be performed as usual by your doctor.

Compensation

Not stated in the trial record.

Follow-up

Your biopsy results will be collected up to 90 days after you join the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.