Status: Recruiting
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
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.
Participants needed: 1,500
Trial details
Age: 45-80Biological sex: MaleType: ObservationalSponsor: Wren Laboratories LLCUpdated: Aug 21, 2026Locations: 1
Eligibility criteria
elevated PSA and/or abnormal digital rectal examination
Previous Prostate cancer diagnosis