Prostate AdenocarcinomaPhase 2NCT06022822
Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Urolithin A Supplement in people with Prostate Adenocarcinoma, run by National Cancer Institute (NCI) at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Urolithin A Supplement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Sep 2024to 1 May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have pathologically confirmed adenocarcinoma of the prostate with formalin-fixed paraffin embedded (FFPE) biopsy tissue available for analysis, including those on active surveillance. Most recent biopsy 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
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Ashley E. Ross, 312-694-1117, ashley.ross1@northwestern.edu
Ashley E. Ross
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Abhinav Sidana, 773-702-1860, abhinav.sidana@bsd.uchicago.edu
Abhinav Sidana
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Judd W. Moul, 919-668-8108, judd.moul@duke.edu
Judd W. Moul
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Stephen J. Freedland, 310-423-3974, Stephen.Freedland@cshs.org
Stephen J. Freedland
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
David F. Jarrard, 608-262-0759, jarrard@urology.wisc.edu
David F. Jarrard
About this study
Official title: A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A) supplements versus placebo on 8-OHdG percent positive change in prostate cancer tumor tissue obtained by core needle biopsy in participants who undergo radical prostatectomy after 3 to 6 weeks of therapy.
SECONDARY OBJECTIVES:
- To determine prostate tissue and plasma concentrations of Uro-A, urolithin sulfate and urolithin A glucuronide, as measured by change from baseline to end-of-study, in comparison to changes from baseline to end-of-study in a control group receiving a placebo (except tissue levels, which will be compared between arms using end-of-study tissue only).
II. To compare the change in expression of cell cycle genes in prostate cancer tumor tissue from pre-study biopsy to radical prostatectomy in men receiving Uro-A supplements for 3 to 6 weeks and a control group of men receiving a placebo.
III. To determine the effect of Uro-A supplements on change in 8-OHdG expression in benign and tumor-adjacent prostatic tissue from pre-study biopsy to radical prostatectomy (RP) following 3-6 weeks of therapy in comparison to a control group of men receiving a placebo.
EXPLORATORY OBJECTIVES:
- To determine the effect of Uro-A supplements on circulating levels of high sensitivity C-reactive protein (hsCRP), TNF-alpha, and IL-6, as measured by change from baseline to end-of-study compared with the men receiving a placebo.
II. To compare change in tumor gene expression patterns of Hallmark androgen signaling between study arms.
III. To determine the effect of a 3-to-6-week intervention of urolithin A (Uro-A) supplements versus placebo on 8-OHdG H-index (percent staining positive at each score in a 0-3 scale) change in prostate cancer tumor tissue obtained by core needle biopsy at baseline and at radical prostatectomy after 3 to 6 weeks of therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive urolithin A orally (PO) twice daily (BID) for 3-6 weeks prior to standard of care (SOC) RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.
ARM II: Patients receive placebo orally (PO) twice daily (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.
Patients are followed up at 2 weeks after surgery.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Biopsy Procedure, Biospecimen Collection, Placebo Administration, Urolithin A Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Placebo AdministrationDrug
Given PO
Urolithin A SupplementDietary supplement
Also called Mitopure, Uro-A Supplement
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (urolithin A) | Experimental | 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. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Dietary Supplement: Urolithin A Supplement |
| Arm II (placebo) | Placebo comparator | 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. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Placebo Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent positive change in 8-OHdG
The primary endpoint will be analyzed using a linear regression model. Standard descriptive statistics, including mean, standard deviation, median and interquartile range for continuous variables, and frequency and percent for categorical variables, will be used to summarize baseline variables by treatment arm. Changes will be summarized similarly. Graphical techniques, including boxplots and histograms, will be used to examine the distribution and to assess assumptions made for the primary analysis.
Measured: Baseline up to radical prostatectomy (RP) after 3 to 6 weeks of therapy
Secondary outcomes (3)
Changes in prostate tissue and plasma concentrations of urolithin A (Uro-A), urolithin sulfate and urolithin A glucuronide
Measured by change from baseline to end-of-study, in comparison to changes from baseline to end-of-study in a control group receiving a placebo (except tissue levels, which will be compared between arms using end-of-tissue only). Will be analyzed using the same approach as the analysis of the primary endpoint. Changes in plasma concentrations of Uro-A, urolithin sulfate and urolithin A glucuronide, from baseline to radical prostatectomy will be estimated and summarized using standard descriptive statistics.
Measured: Baseline up to 2 years
Changes in expression of cell cycle genes
The ribonucleic sequencing will be used to compute a single z-score (i.e. one data point per patient) which will represent the composite expression of 31 cell-cycle genes.
Measured: Baseline up to RP after 3 to 6 weeks of therapy
Changes in 8-OHdG expression
Measured: Baseline up to RP after 3 to 6 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start12 Sep 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen J Freedland, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022822
- Sponsor's protocol ID
- NCI-2023-03835
- Other IDs
- NCI-2023-03835, NCI22-12-01, NWU22-12-01, P30CA060553, UG1CA189828, UG1CA242643
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.