Home › Prostate Cancer › 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
RecruitingObservational study
Who can join
Ages 45 to 80 · Men
Full eligibility criteria
Inclusion Criteria: * elevated PSA and/or abnormal digital rectal examination Exclusion Criteria: * Previous Prostate cancer diagnosis
About the study
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.
What is being tested
- PROSTEST (diagnostic test)
Sponsor: Wren Laboratories LLC · Participants: 1,500 · Started: Apr 15, 2026
Contact the study team
- Mark Kidd, PhD · Phone: 2038241128
- Tracy Auster, BS · Phone: 2032083464
Official record on ClinicalTrials.gov — NCT07454603
Locations in the U.S.
| Connecticut | Wren Laboratories, Branford |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.