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Journal Mitochondrial biology
Discovery

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

Hypothesis
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Editor's note
Urolithin A may reduce tumor-driving oxidative stress by enhancing mitochondrial recycling—a testable mechanism that could shift prostate cancer from chemotherapy toward metabolic intervention. This phase II trial directly measures mitophagy activation in human tissue rather than cell culture, grounding a speculative pathway in clinical reality. Oncologists treating localized prostate cancer and researchers investigating mitochondrial-targeted therapies will watch whether the oxidative stress biomarker predicts clinical benefit.

Source: ctgov · National Cancer Institute (NCI) · RECRUITING · 2026-05-13

URL: https://clinicaltrials.gov/study/NCT06022822

AI rationale (4/5, tier: emerging): Phase II RCT of urolithin A (explicit PRIORITISE item) measuring mitophagy-linked oxidative stress endpoint in human tissue.


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.

Published 2026-05-28 · Last kit-update 2026-05-28