Major Program
Cancer Prevention Clinical Trials Network
Research Group
Prostate and Urologic Cancer
Sponsor
National Cancer Institute (NCI)
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT06022822
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.
Intervention
Biopsy, Biospecimen Collection, Placebo Administration, Urolithin A Supplement
Condition
Prostate Adenocarcinoma
Investigators
Stephen J Freedland, Ashley E. Ross, David F. Jarrard, Judd W. Moul, Scott E. Eggener