Recruiting

Urolithin A Supplementation Impact on Prostate Cancer Prevention in Men Undergoing Radical Prostatectomy

Study Aim

This phase 2 study aims to evaluate how Urolithin A supplementation can prevent prostate cancer in men undergoing radical prostatectomy, by measuring the positive change in a specific marker called 8-OHdG.

What is being tested

Biopsy Procedure

+ Biospecimen Collection

+ Urolithin A Supplement

ProcedureDietary SupplementDrug

Who is being recruted

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-ControlledPhase 2

Interventional

Study Start: September 2024

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 12, 2024

Actual date on which the first participant was enrolled.

This study focuses on men with prostate cancer who are about to undergo a radical prostatectomy, a surgical procedure to remove the prostate gland. The main goal is to evaluate the effects of a supplement called Urolithin A (Uro-A) compared to a placebo. The study aims to understand if Uro-A can positively impact the prostate cancer tumor tissue. This research is important as it could potentially improve the care for prostate cancer patients and address current challenges in treatment. Participants in this study are divided into two groups. One group receives Uro-A supplements orally twice a day for 3-6 weeks before the surgery, while the other group receives a placebo. Both groups undergo a biopsy at the time of surgery and provide blood samples during screening and throughout the study. The study measures the results by looking at changes in the prostate tissue and blood, specifically focusing on the levels of a marker called 8-OHdG and the concentration of Uro-A. The study also evaluates changes in the expression of certain genes and inflammation markers. Participants are followed up 2 weeks after surgery.

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

NCT06022822

Principal SponsorNational Cancer Institute (NCI)

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

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

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6 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Patients receive urolithin A PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.

Group II

Placebo

Patients receive placebo PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Cedars Sinai Medical Center

Los Angeles, United StatesOpen Cedars Sinai Medical Center in Google Maps

Recruiting

Northwestern University

Chicago, United States

Recruiting

University of Chicago Comprehensive Cancer Center

Chicago, United States

Recruiting

Duke University Medical Center

Durham, United States

Recruiting

5 Study Centers