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Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
NCT06022822 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- DRUG Placebo Administration
- DIETARY_SUPPLEMENT Urolithin A Supplement
Study Locations (5)
Illinois
- Northwestern University — Chicago
- University of Chicago Comprehensive Cancer Center — Chicago
California
- Cedars Sinai Medical Center — Los Angeles
North Carolina
- Duke University Medical Center — Durham
Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-09-12 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06022822
The ClinicalTrials.gov registry entry for NCT06022822 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06022822 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Illinois, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06022822 about?
NCT06022822 is a clinical study titled "Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial". 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 dail...
What is the current status of trial NCT06022822?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-09-12. Estimated completion is 2027-05-01.
What conditions does trial NCT06022822 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06022822?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Placebo Administration (DRUG), Urolithin A Supplement (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06022822?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06022822 being conducted?
This trial has 5 study locations across California, Illinois, North Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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