Actively Recruiting
Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
90
Participants Needed
5
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with biopsy-confirmed adenocarcinoma of the prostate and formalin-fixed paraffin embedded biopsy tissue available for analysis, including those on active surveillance
- Biopsy performed within six months prior to registration or randomization
- Male participants aged 18 years or older
- Participants with HIV on effective anti-retroviral therapy and undetectable viral load within 6 months
- Participants with chronic hepatitis B virus infection must have undetectable viral load on suppressive therapy if needed
- Participants with history of hepatitis C infection must be treated and cured or have undetectable viral load if currently on treatment
- Participants on chronic suppressive antiviral therapy for herpes simplex virus
- Scheduled to undergo radical prostatectomy in 3 to 6 weeks
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior primary treatment or hormonal therapy for prostate cancer
- Active alcohol or illegal substance dependency
- Currently receiving urolithin A (Mitopure) or pomegranate supplements
- Receiving any other investigational agents
- History of allergic reactions to compounds similar to urolithin A
- Uncontrolled illness or psychiatric/social conditions limiting compliance with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
5
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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