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

Part of paid clinical trials in Branford, Connecticut.

Sponsor
Wren Laboratories LLC
Study ID
NCT07454603
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • PROSTEST — DIAGNOSTIC_TEST
    BLOOD SAMPLE FOR PROSTEST MEASUREMENT

Study Details

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.

Key Dates

First listed
Mar 6, 2026
Start date
Apr 15, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
1,500 participants (estimated)

Primary Outcome Measure

Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy [ Time Frame: Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wren LaboratoriesBranfordConnecticut06405
Mark Kidd, PhD
[email protected]
2038241128
Tracy Auster, BS
[email protected]
2032083464

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Wren Laboratories· Branford, CT

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