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
NCT07454603
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Prostate Cancer
- Urology
- Prostate Cancer (Diagnosis)
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- 45 to 80 years
- Sex
- Male
- Healthy volunteers
- Not accepted
- Sponsor
- Wren Laboratories LLC
- Last updated on ClinicalTrials.gov
- August 21, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Connecticut · 1
- Wren Laboratories · Branford, CT
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.