Urolithin A supplementation for men with prostate cancer before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II randomized control trial evaluates the effects of Urolithin A supplementation compared to a placebo in men diagnosed with prostate adenocarcinoma who are scheduled for radical prostatectomy. A total of 90 participants will be randomly assigned to receive either 1000 mg of Urolithin A daily or a placebo for a duration of 3 to 6 weeks prior to their surgery. The primary goal is to assess the impact of Urolithin A on reducing oxidative stress in prostate tumor tissue, measured by changes in specific biomarkers. Secondary objectives include analyzing the concentration of Urolithin A and its metabolites in prostate tissue and plasma, as well as changes in gene expression related to cancer progression.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Stephen J Freedland — Cedars-Sinai Medical Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.