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

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.

NCT Number	NCT07454603
Lead Sponsor	Wren Laboratories LLC
Conditions	Prostate Cancer, Urology, Prostate Cancer (Diagnosis)
Enrollment	1,500 participants
Start Date	2026-03-15
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-06