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

Description

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.

Conditions

Prostate Adenocarcinoma

Study Overview

Study Details

Study overview

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.

A Phase II Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy

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

Condition
Prostate Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Chicago

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States, 60637

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Madison

University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must have pathologically confirmed adenocarcinoma of the prostate with formalin-fixed paraffin embedded (FFPE) biopsy tissue available for analysis. Diagnosis can be any time in the six months prior to registration/randomization
  • * Participants \>= 18 years will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of urolithin A in participants \< 18 years of age, children and adolescents are excluded from this study
  • * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
  • * Absolute neutrophil count \>= 1,000/microliter
  • * Platelets \>= 100,000/microliter
  • * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) Note: Higher total bilirubin levels (=\< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's
  • * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal
  • * Creatinine =\< 1.5 x institutional upper limit of normal
  • * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • * Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
  • * Scheduled to undergo RP in the next 3-6 weeks
  • * Ability to understand and the willingness to sign a written informed consent document
  • * Participants with prior primary treatment or hormonal therapy for prostate cancer (PC)
  • * Participants with documented active alcohol and illegal substance dependency
  • * Participants already receiving urolithin A (Mitopure, commercially available in the United States), or pomegranate supplements. Note: Other supplements are allowed but must be documented
  • * Participants receiving any other investigational agents
  • * History of allergic reactions attributed to compounds of similar chemical or biologic composition to urolithin A
  • * Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Cancer Institute (NCI),

Stephen J Freedland, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2027-05-01