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
Purpose
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.
Conditions
- Prostate Cancer
- Urology
- Prostate Cancer (Diagnosis)
Eligibility
- Eligible Ages
- Between 45 Years and 80 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- elevated PSA and/or abnormal digital rectal examination
Exclusion Criteria
- Previous Prostate cancer diagnosis
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Branford, Connecticut 06405
More Details
- Status
- Recruiting
- Sponsor
- Wren Laboratories LLC
Detailed Description
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. Diagnostic performance metrics including sensitivity, specificity, negative predictive value, and area under the receiver operating characteristic curve will be calculated. Decision-curve analyses will assess potential reductions in unnecessary biopsies. Exploratory analyses will evaluate correlations between PROSTest scores, MRI findings, and pathologic grade group. Endpoints: Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Secondary endpoints include negative predictive value, correlation with Gleason grade group, and incremental performance of PROSTest when combined with PSA and MRI. Trial Status: IRB approval is complete. Enrollment is expected to begin in March 2026, with a planned sample size of approximately [1,500] participants.