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PROSTest for Prostate Cancer Risk Assessment

This study is looking at a blood test called PROSTest to help doctors decide if men with suspected prostate cancer need a biopsy. You might be eligible if you are a man between 45 and 80 years old, and your doctor has recommended a prostate biopsy because of a high PSA (prostate-specific antigen) level or an abnormal digital rectal exam. The study will collect a blood sample from you before your biopsy. Researchers will then compare the PROSTest results with your biopsy results to see how accurately PROSTest can detect prostate cancer. The main goal is to see if PROSTest can help reduce unnecessary biopsies. Enrollment is expected to begin in March 2026.

Study design
This is an observational study involving about 1,500 men. Researchers will analyze the PROSTest results without knowing your biopsy results.
What's involved
You will provide a blood sample before your prostate biopsy. The study is anticipated to enroll over a year and be completed within 18 months.
Compensation
Not stated in the trial record.
Follow-up
Your PROSTest results will be evaluated after the study is completed, which is anticipated within 18 months.

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NCT07454603

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

Recruiting
Not specifiedAges 45–80Observational
Wren Laboratories LLC
~1,500 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:PROSTEST

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
Measured over Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.

Conditions

Prostate Cancer
Urology
Prostate Cancer (Diagnosis)

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Abdel Halim, PharmD, PhD · STUDY_CHAIR · Wren Laboratories

Who to contact

Mark Kidd, PhD
[email protected]
2038241128
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

elevated PSA and/or abnormal digital rectal examination

Exclusion

Previous Prostate cancer diagnosis

What this trial measures

  • Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsyFollowing completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.

    Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Assay is scored 0-100 and has a cut-off of 50 for normal. A blood sample with a PROSTest score \> or equal than 50 are predicted to be a prostate cancer. The expectation is that \>85% of individuals who are biopsy positive are also PROSTest-positive. We anticipate \~400 individuals will be biopsy positive. Conversely, the expectation is that \>75% of individuals who are biopsy negative will also be PROSTest-negative. We anticipate \~600 individuals will be biopsy negative. This will allow us to derive diagnostic metrics for the assay using biopsy-status as the gold standard.