RECRUITING Phase 2 ClinicalTrials.gov

Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06022822

Registry updated: 2026-08-25

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Description

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.

Interventions

Biopsy Procedure (Procedure)
Undergo biopsy
Biospecimen Collection (Procedure)
Undergo collection of blood samples
Placebo Administration (Drug)
Given PO
Urolithin A Supplement (Dietary supplement)
Given PO

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Conditions

Prostate Adenocarcinoma

Locations

Cedars-Sinai Medical Center — Los Angeles, California, United States
Northwestern University — Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Duke University Medical Center — Durham, North Carolina, United States
University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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