Clinical trial · Interventional
Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Procedure | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Placebo Administration | Drug | — | UNRESOLVED |
| Urolithin A Supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (urolithin A)
- description
- Patients receive urolithin A PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.
- interventionNames
- Procedure: Biopsy Procedure
- Procedure: Biospecimen Collection
- Dietary Supplement: Urolithin A Supplement
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.
- interventionNames
- Procedure: Biopsy Procedure
- Procedure: Biospecimen Collection
- Drug: Placebo Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available