Trials / Not Yet Recruiting

Not Yet RecruitingNCT07454603

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

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 1,500 (estimated)

Sponsor: Wren Laboratories LLC · Industry
Sex: Male
Age: 45 Years – 80 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PROSTEST	BLOOD SAMPLE FOR PROSTEST MEASUREMENT

Timeline

Start date: 2026-03-15
Primary completion: 2027-02-28
Completion: 2027-06-01
First posted: 2026-03-06
Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07454603. Inclusion in this directory is not an endorsement.