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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06022822
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Placebo Administration — DRUG
    Given PO
  • Urolithin A Supplement — DIETARY_SUPPLEMENT
    Given PO

Study Details

This phase II randomized control trial assesses the effect of Urolithin A (Uro-A) supplementation compared to placebo in men with biopsy-confirmed prostate cancer undergoing radical prostatectomy (RP) progressive disease. A total of 90 men will be accrued and randomized 1:1 to receive a 1000 mg daily dose of Uro-A in two 250 mg capsules PO BID or two placebo capsules BID daily for 3 to 6 weeks prior to RP. The primary endpoint is to determine the effect of Uro-A on decreasing prostate tumor tissue oxidative stress (measured by 8-OHdG) compared to placebo.

Key Dates

Start date
Sep 12, 2024
Status verified
Feb 2026
Primary completion
Nov 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm I (urolithin A)
    Patients receive urolithin A PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.

Primary Outcome Measure

Percent positive change in 8-OHdG [ Time Frame: Baseline up to radical prostatectomy (RP) after 3 to 6 weeks of therapy ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Stephen J. Freedland
[email protected]
310-423-3974
Stephen J. Freedland (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Ashley E. Ross
[email protected]
312-694-1117
Ashley E. Ross (PRINCIPAL_INVESTIGATOR)
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
Abhinav Sidana
[email protected]
773-702-1860
Abhinav Sidana (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Judd W. Moul
[email protected]
919-668-8108
Judd W. Moul (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
David F. Jarrard
[email protected]
608-262-0759
David F. Jarrard (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CANorthwestern University· Chicago, ILUniversity of Chicago Comprehensive Cancer Center· Chicago, ILDuke University Medical Center· Durham, NCUniversity of Wisconsin Carbone Cancer Center - University Hospital· Madison, WI

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