Purpose of this Study
We are doing this study is to compare the effects of Urolithin A and placebo (an inactive substance with no medicinal properties) on the biological composition of the prostate in men with prostate cancer. In this study, you will have an equal chance of either taking Urolithin A or placebo.
Who Can Participate?
Eligibility
Men ages 18+ who:
- Were diagnosed with prostate cancer within 6 months of joining the study
- Are scheduled to have surgery to remove the prostate
- Have not received any hormonal therapy
- Are not currently using any Urolithin A supplements (e.g., Mitopure)
Age Range
18-110
Sex/Genders
Male (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to either take Urolithin A or a placebo. Urolithin A is a supplement that is found naturally in certain fruits and nuts, and it can also be produced by our gut bacteria.
After you get your assignment, you will:
- Take Urolithin A or the placebo twice a day for 3-6 weeks before your scheduled surgery
- Keep a diary about any possible side effects you have while taking your assigned pills
- Have some tissue from your prostate sampled for testing
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A PHASE 2 PLACEBO-CONTROLLED TRIAL OF UROLITHIN A SUPPLEMENTATION IN MEN WITH PROSTATE CANCER UNDERGOING RADICAL PROSTATECTOMY
Study Website
Principal Investigator
Judd
Moul
Protocol Number
PRO00112750
NCT ID
NCT06022822
Phase
II
Enrollment Status
Open to Enrollment