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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 weakened immune system 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 willing to sign a consent form document Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Placebo Administration

Given PO

DIETARY_SUPPLEMENT

Urolithin 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