Do you have Prostate Cancer?
Prostate Cancer (PC) is the most common type of cancer in men in the United States. One common treatment for patients who have been diagnosed with PC is surgery to remove the prostate (prostatectomy). We are conducting a study to determine whether an over-the-counter dietary supplement (Urolithin A) may have the potential to delay the progression of prostate cancer in hopes of reducing or delaying the need for prostate surgery in future patients.
Testing Urolithin A in patients with prostate cancer
Stephen J. Freedland, MD - Cedars-Sinai Medical Center
Michael Abern, MD - Duke University
This study focuses on Urolithin A, a natural compound produced by gut bacteria after eating certain plant-based foods, such as pomegranates, berries, and some varieties of nuts. Urolithin A has antioxidant properties and may have anticancer effects. An antioxidant is a substance that protects cells from the damage caused by free radicals (unstable molecules made by the process of oxidation during normal metabolism). Free radicals may play a part in cancer, heart disease, stroke, and other diseases of aging. Antioxidants include beta-carotene, lycopene, vitamins A, C, and E, and other natural and manufactured substances. The goal of this study is to assess whether taking this supplement produces detectable levels of Urolithin A in the prostate and leads to detectable antioxidant activity.
If you decide to take part in this study, you will be randomly assigned to take either Urolithin A gel Capsules or Placebo gel capsules by mouth twice a day for 3-6 weeks (a four-week extension is allowed for surgical delays). A placebo is an inactive substance that looks like the study drug but contains no medication. You can also expect physical exams, blood draws, review of your medical history and completion of questionnaires.
After completing the study drug, your study doctor will continue to follow your condition and watch for any side effects for up to two weeks after your surgery.
We will enroll 90 men at institutions across the country. You may be eligible if you:
Are over 18 years of age.
Have been diagnosed with prostate cancer in the last 6 months.
Are planning to have surgery to remove the prostate in the next 3-6 weeks.
If you think you may be eligible, you can contact a study coordinator: firstname.lastname@example.org
Site: Northwestern University, Chicago, IL
Site Principal Investigator: Ashley E. Ross, MD, PhD
Site: Cedars-Sinai Medical Center, Los Angeles, CA
Site Principal Investigator: Sunyong You, PhD
Site: University of Chicago, Chicago, IL
Site Principal Investigator: Scott Eggener, MD
Site: Duke University, Durham, NC
Site Principal Investigator: Judd Moul, MD
Site: University of Wisconsin Carbone Cancer Center, NC Madison, WI
Site Principal Investigator: David F. Jarrard, MD
More Infromation: https://clinicaltrials.gov/study/NCT06022822