Urolithin A supplementation for men with prostate cancer before surgery
A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy
This study is testing if taking Urolithin A before surgery can help men with prostate cancer by reducing stress in their tumor tissue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | National Cancer Institute (NCI) NIH |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06022822 on ClinicalTrials.gov |
What this trial studies
This phase II randomized control trial evaluates the effects of Urolithin A supplementation compared to a placebo in men diagnosed with prostate adenocarcinoma who are scheduled for radical prostatectomy. A total of 90 participants will be randomly assigned to receive either 1000 mg of Urolithin A daily or a placebo for a duration of 3 to 6 weeks prior to their surgery. The primary goal is to assess the impact of Urolithin A on reducing oxidative stress in prostate tumor tissue, measured by changes in specific biomarkers. Secondary objectives include analyzing the concentration of Urolithin A and its metabolites in prostate tissue and plasma, as well as changes in gene expression related to cancer progression.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with biopsy-confirmed prostate adenocarcinoma who are scheduled for radical prostatectomy.
Not a fit: Patients with prostate cancer who are not undergoing radical prostatectomy or those under 18 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary supplement approach to reduce oxidative stress in prostate cancer patients, potentially improving surgical outcomes.
How similar studies have performed: While the specific use of Urolithin A in this context is novel, similar studies exploring dietary supplements for cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 4 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Stephen J Freedland — Cedars-Sinai Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.