A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer

Starting soon

Conditions studied: Prostate Cancer, Urology, Prostate Cancer (Diagnosis)

In brief

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.

Key facts

Study ID

NCT07454603

Run by

Wren Laboratories LLC

People needed

1500

Starts

2026-03-15

Expected to finish

2027-06-01

Last updated by the study team

2026-03-06

Who can join

Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• elevated PSA and/or abnormal digital rectal examination

You may not qualify if…

• Previous Prostate cancer diagnosis

Where it is running

• Wren Laboratories — Branford, Connecticut, United States

Full record on ClinicalTrials.gov

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