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

About This Trial

This study is testing whether a supplement called Urolithin A can help reduce cell stress and damage inside prostate tumor tissue.
It is open to adults with prostate cancer who are scheduled to have surgery to remove their prostate within the next three to six weeks and have not yet received other cancer treatments.
If you take part, you will take study capsules twice a day leading up to your surgery.
You should know that you have a 50-50 chance of receiving either the real supplement or an inactive dummy pill (placebo).
Finally, you cannot join the study if you already take pomegranate supplements or products containing Urolithin A.

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.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing whether a supplement called Urolithin A can help reduce cell stress and damage inside prostate tumor tissue.

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