NCT06022822 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
| NCT ID | NCT06022822 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-09-12 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-09-12 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Stephen J Freedland
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT06022822 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06022822 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06022822 currently recruiting?
Yes, NCT06022822 is actively recruiting participants. Visit ClinicalTrials.gov or contact National Cancer Institute (NCI) to inquire about joining.
Where is the NCT06022822 trial being conducted?
This trial is being conducted at Los Angeles, United States, Chicago, United States, Chicago, United States, Durham, United States and 1 additional location.
Who is sponsoring the NCT06022822 clinical trial?
NCT06022822 is sponsored by National Cancer Institute (NCI). The principal investigator is Stephen J Freedland at Cedars-Sinai Medical Center. The trial plans to enroll 90 participants.