Recruiting
Phase 2

Urolithin A

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06022822

Conditions

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Placebo Administration

Urolithin A Supplement

Study Details

Brief 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.

Conditions

Prostate Adenocarcinoma

Study ID

NCT06022822

Start date

Sep 12, 2024

Status verified date

Aug, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm I (urolithin A)

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.

placebo comparator: Arm 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.

Interventions

Biopsy Procedure

Undergo biopsy

Biospecimen Collection

Undergo collection of blood samples

Placebo Administration

Given PO

Urolithin A Supplement

Given PO

Primary outcome measure

  • Percent positive change in 8-OHdG [ Time Frame: Baseline up to radical prostatectomy (RP) after 3 to 6 weeks of therapy ]

Central Contacts and Locations

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Stephen J. Freedland

310-423-3974Stephen.Freedland@cshs.org

Principal Investigator:

Stephen J. Freedland

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Ashley E. Ross

312-694-1117ashley.ross1@northwestern.edu

Principal Investigator:

Ashley E. Ross

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Abhinav Sidana

773-702-1860abhinav.sidana@bsd.uchicago.edu

Principal Investigator:

Abhinav Sidana

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Judd W. Moul

919-668-8108judd.moul@duke.edu

Principal Investigator:

Judd W. Moul

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

David F. Jarrard

608-262-0759jarrard@urology.wisc.edu

Principal Investigator:

David F. Jarrard

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-25.