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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

RECRUITINGSponsored by Wren Laboratories LLC
Actively Recruiting
SponsorWren Laboratories LLC
Started2026-04-15
Est. completion2027-02-28
Eligibility
Age45 Years – 80 Years
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07454603

Summary

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.

Eligibility

Age: 45 Years – 80 YearsSex: MALEHealthy volunteers accepted
Inclusion Criteria:

* elevated PSA and/or abnormal digital rectal examination

Exclusion Criteria:

* Previous Prostate cancer diagnosis

Conditions4

CancerProstate CancerProstate Cancer (Diagnosis)Urology

Locations1 site

Wren Laboratories
Branford, Connecticut, 06405
Mark Kidd, PhD2038241128mkidd@wrenlaboratories.com

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