Who is eligible for clinical trial NCT06022822?

Participants must meet protocol criteria for Prostate Adenocarcinoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06022822 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-22

Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial (NCT06022822)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 Plain-English Summary (8th-Grade Level)

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 can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (7 items).

Location: Cedars-Sinai Medical Center — Los Angeles, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗