RecruitingNCT07454603

A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth

Sponsor

Wren Laboratories LLC

Enrollment

1,500 participants

Start Date

Apr 15, 2026

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer Prostate Cancer (Diagnosis)Urology

Summary

This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.

Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying PROSTEST for people with prostate cancer, prostate cancer (diagnosis), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 45 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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