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NCT06022822 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostate Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
90
Enrollment target
5
Study locations

NCT06022822 is a Phase 2 study of Prostate Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 90 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (59% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT06022822, a Phase 2 study of Prostate Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
90 participants
Enrollment target
5
Study locations

Study Summary

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 Studied

Prostate Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Biopsy Procedure
  • DRUG Placebo Administration
  • DIETARY_SUPPLEMENT Urolithin A Supplement

Study Locations (5)

Illinois

  • Northwestern University - Chicago
  • University of Chicago Comprehensive Cancer Center - Chicago

California

  • Cedars Sinai Medical Center - Los Angeles

North Carolina

  • Duke University Medical Center - Durham

Wisconsin

  • University of Wisconsin Carbone Cancer Center - University Hospital - Madison

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-09-12
Est. Completion 2027-05-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT06022822

The ClinicalTrials.gov registry entry for NCT06022822 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (59% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.

NCT06022822 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Illinois, California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06022822 about?

NCT06022822 is a clinical study titled "Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial". 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 dail...

What is the current status of trial NCT06022822?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-09-12. Estimated completion is 2027-05-01.

What conditions does trial NCT06022822 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma.

What interventions are being tested in trial NCT06022822?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Placebo Administration (DRUG), Urolithin A Supplement (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06022822?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06022822 being conducted?

This trial has 5 study locations across California, Illinois, North Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.