Study on Urolithin A Supplementation in Men with Prostate Cancer Undergoing Surgery

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06022822

Provider View

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

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.

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