Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Prostate Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT06022822
- Run by
- National Cancer Institute (NCI)
- People needed
- 90
- Starts
- 2024-09-12
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Participants who have pathologically confirmed adenocarcinoma of the prostate with formalin-fixed paraffin embedded (FFPE) biopsy tissue available for analysis, including those on active surveillance. Most recent biopsy can be any time in the six months prior to registration/randomization
- Participants >= 18 years will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of urolithin A in participants < 18 years of age, children and adolescents are excluded from this study
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
- Scheduled to undergo RP in the next 3-6 weeks
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if…
- Participants with prior primary treatment or hormonal therapy for prostate cancer (PC)
- Participants with documented active alcohol and illegal substance dependency
- Participants already receiving urolithin A (Mitopure, commercially available in the United States), or pomegranate supplements. Note: Other supplements are allowed but must be documented
- Participants receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to urolithin A
- Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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