🔎 Trials Near Me

Home › NCT06022822

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

RecruitingPhase 2

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

Who can join

Ages 18 and older · Men

Full 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

About the study

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.

What is being tested

Sponsor: National Cancer Institute (NCI) · Participants: 90 · Started: Sep 12, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06022822

Locations in the U.S.

CaliforniaCedars-Sinai Medical Center, Los Angeles
IllinoisNorthwestern University, Chicago
University of Chicago Comprehensive Cancer Center, Chicago
North CarolinaDuke University Medical Center, Durham
WisconsinUniversity of Wisconsin Carbone Cancer Center - University Hospital, Madison

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.