RecruitingPhase 2NCT06022822

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

A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy


Sponsor

National Cancer Institute (NCI)

Enrollment

90 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This placebo-controlled trial tests whether urolithin A (a natural supplement that supports cellular energy and mitochondrial health) taken before prostate removal surgery can affect prostate cancer biology in men with confirmed prostate adenocarcinoma. **You may be eligible if...** - You are a male 18 or older with biopsy-confirmed prostate adenocarcinoma - You are scheduled for radical prostatectomy (surgical removal of the prostate) in the next 3–6 weeks - You have adequate liver function - HIV-positive patients on effective treatment with undetectable viral load are eligible **You may NOT be eligible if...** - You have had prior primary treatment or hormonal therapy for prostate cancer - You already take urolithin A (Mitopure) or pomegranate supplements - You have active alcohol or substance dependency - You have a known allergy to urolithin A - You have uncontrolled medical illness or psychiatric conditions affecting compliance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

DRUGPlacebo Administration

Given PO

DIETARY_SUPPLEMENTUrolithin A Supplement

Given PO


Locations(5)

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

View Full Details on ClinicalTrials.gov

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NCT06022822


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