Study on Urolithin A Supplementation in Men with Prostate Cancer Undergoing Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06022822
This clinical trial is testing whether Urolithin A supplements can help reduce oxidative stress in prostate cancer tissue in men scheduled for prostate surgery. Participants will receive either the supplement or a placebo for 3 to 6 weeks before their surgery.
Patient Parameters
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Program Overview
This study is exploring the effects of Urolithin A, a dietary supplement, on prostate cancer in men who are scheduled to have their prostate removed due to cancer. The trial will compare the supplement to a placebo to see if it can reduce oxidative stress in the cancer tissue. A total of 90 men will participate, with half receiving the supplement and the other half receiving a placebo for 3 to 6 weeks before their surgery. The main goal is to see if Urolithin A can lower oxidative stress in the prostate cancer tissue compared to the placebo.
Description
The primary aim of this study is to find out if taking Urolithin A supplements for 3 to 6 weeks can reduce oxidative stress in prostate cancer tissue, as measured by a specific marker, compared to a placebo.
Secondary goals include:
- Measuring the levels of Urolithin A and its byproducts in prostate tissue and blood.
- Comparing changes in certain genes related to cell growth in cancer tissue between those taking the supplement and those taking a placebo.
- Assessing the effect of Urolithin A on oxidative stress in non-cancerous prostate tissue.
Exploratory goals include:
- Evaluating changes in inflammation markers in the blood.
- Analyzing changes in gene expression related to hormone signaling in cancer tissue.
- Collecting stool samples to study changes in gut bacteria.
Participants will be randomly assigned to one of two groups:
- Group 1 will take Urolithin A supplements and provide blood and tissue samples.
- Group 2 will take a placebo and provide similar samples.
All participants will be followed up two weeks after their surgery to assess outcomes.
Eligibility Criteria
Inclusion Criteria
- Men with confirmed prostate cancer and available biopsy tissue.
- Aged 18 years or older.
- Good general health with a performance status score of 2 or less.
- Adequate blood cell counts and liver function.
- HIV-positive individuals on effective treatment with undetectable viral load are eligible.
- Those with controlled hepatitis B or cured hepatitis C are eligible.
- Scheduled for prostate surgery in the next 3 to 6 weeks.
- Able to understand and sign a consent form.
Exclusion Criteria
- Previous treatment for prostate cancer.
- Active alcohol or illegal drug dependency.
- Currently taking Urolithin A or pomegranate supplements.
- Participation in other investigational drug studies.
- Allergies to similar compounds as Urolithin A.
- Uncontrolled health conditions or psychiatric issues that could affect study participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| Northwestern University | 60611 | Chicago | Illinois |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Duke University Medical Center | 27710 | Durham | North Carolina |
| University of Wisconsin Carbone Cancer Center - University Hospital | 53792 | Madison | Wisconsin |
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