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

Sponsor
National Cancer Institute (NCI)
Status
Not yet 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

See list of participating sites