Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Ra… (NCT06022822) | Clinical Trial Compass
RecruitingPhase 2
Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
United States90 participantsStarted 2024-09-12
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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…
What they're measuring
1
Percent positive change in 8-OHdG
Timeframe: Baseline up to radical prostatectomy (RP) after 3 to 6 weeks of therapy