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Urolithin A Supplementation for Prostate Cancer

Phase 2

Waitlist Available

Led By Stephen J Freedland

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 2 years

Awards & highlights

Study Summary

This trial is testing a drug to see if it reduces prostate cancer growth by blocking the effect of testosterone. It may lead to new treatments for men with prostate cancer.

Who is the study for?

Men with confirmed prostate cancer scheduled for surgery can join this trial. They must have good blood counts, liver and kidney function, and controlled hepatitis or HIV if present. Men over 18 years old who haven't had prior treatments for prostate cancer or are taking similar supplements to Urolithin A are eligible.Check my eligibility

What is being tested?

The URO-PRO trial is testing whether a supplement called Urolithin A can reduce oxidative stress in the prostate before surgery compared to a placebo. Participants will take either the supplement or placebo daily for 3-6 weeks before their operation.See study design

What are the potential side effects?

Specific side effects of Urolithin A aren't detailed here, but participants will be monitored for any adverse reactions since it's under study. Common supplement risks may include digestive discomfort, allergic reactions, or interactions with other medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent positive change in 8-OHdG

Secondary outcome measures

Changes in 8-OHdG expression

Changes in expression of cell cycle genes

Changes in prostate tissue and serum concentrations of urolithin A (Uro-A), urolithin sulfate and urolithin A glucuronide

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (urolithin A)Experimental Treatment3 Interventions

Patients receive urolithin A PO on study. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study. Patients may also undergo collection of stool samples during screening and on study.

Group II: Arm II (placebo)Placebo Group3 Interventions

Patients receive placebo PO on study. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study. Patients may also undergo collection of stool samples during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,577 Total Patients Enrolled

Stephen J FreedlandPrincipal InvestigatorCedars-Sinai Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct locations are currently executing this experiment?

"At the moment, enrolment for this trial is being offered in 5 cities including Chicago, Durham and Madison. It's beneficial to select a local clinic if you wish to be involved as it can help reduce travel costs."

Answered by AI

Has Arm I (urolithin A) been granted clearance from the Food and Drug Administration?

"With limited clinical evidence supporting efficacy, urolithin A scored a 2 on Power's safety metric scale of 1 to 3."

Answered by AI

Are there still unfilled slots for participants in this research endeavor?

"The clinicaltrials.gov registry confirms that this particular trial, first posted on February 17th 2024 and last updated September 7th 2023, is no longer recruiting participants for the study. However, there are currently 834 other studies in search of suitable patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial

2024. "Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06022822.

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