Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
NCT06022822
This study is recruiting at 5 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
Summary
This phase II randomized control trial assesses the effect of Urolithin A (Uro-A) supplementation compared to placebo in men with biopsy-confirmed prostate cancer undergoing radical prostatectomy (RP) progressive disease. A total of 90 men will be accrued and randomized 1:1 to receive a 1000 mg daily dose of Uro-A in two 250 mg capsules PO BID or two placebo capsules BID daily for 3 to 6 weeks prior to RP. The primary endpoint is to determine the effect of Uro-A on decreasing prostate tumor tissue oxidative stress (measured by 8-OHdG) compared to placebo.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Prostate Adenocarcinoma
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 years and older
- Sex
- Male
- Healthy volunteers
- Not accepted
- Sponsor
- National Cancer Institute (NCI)
- Last updated on ClinicalTrials.gov
- August 25, 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
California · 1
- Cedars-Sinai Medical Center · Los Angeles, CA
Illinois · 2
- Northwestern University · Chicago, IL
- University of Chicago Comprehensive Cancer Center · Chicago, IL
North Carolina · 1
- Duke University Medical Center · Durham, NC
Wisconsin · 1
- University of Wisconsin Carbone Cancer Center - University Hospital · Madison, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.