Status:
RECRUITING
Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
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)...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A) supplements versus placebo on 8-OHdG percent positive change in prostate cancer tumor tissue obtaine...
Eligibility Criteria
Inclusion
- Participants must have pathologically confirmed adenocarcinoma of the prostate with formalin-fixed paraffin embedded (FFPE) biopsy tissue available for analysis. Diagnosis 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
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Absolute neutrophil count \>= 1,000/microliter
- Platelets \>= 100,000/microliter
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) Note: Higher total bilirubin levels (=\< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal
- Creatinine =\< 1.5 x institutional upper limit of normal
- 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
- 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
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06022822
Start Date
September 12 2024
End Date
May 1 2027
Last Update
January 9 2026
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Northwestern University
Chicago, Illinois, United States, 60611
3
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
4
Duke University Medical Center
Durham, North Carolina, United States, 27710