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A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy | Clinical Trials | Clareo Health

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A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy

A Randomized, Placebo-controlled, Pre-surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy

NCT00719030•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X) and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient.

Detailed Description

Subjects will receive POM-X or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. Biomarkers in the blood, urine, and prostate tissue will be assessed.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs.
•2. Radical prostatectomy scheduled at Duke or Johns Hopkins.
•3. Initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review.
•4. Age ≥ 18 years of age.
•5. Willingness and ability to sign an informed consent document.
•6. Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
•7. No prior allergy to pomegranate dietary agents.
•8. No significant medical or psychiatric condition that would make the patient a poor protocol candidate.
•9. The patient agrees to stop taking dietary or vitamin supplements (lycopene, vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto) for 2-weeks prior to staring the study.
•10. The patient is not taking LHRH agonists, androgen receptor blocking agents or finasteride, and has not undergone bilateral orchiectomy.
+1 more criteria

Exclusion Criteria

•1. Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate.
•2. Concomitant or antecedent hormonal therapy.
•3. Known allergy to pomegranate juice.
•4. Subjects unable or unwilling to comply with protocol requirements.
•5. Evidence of metastatic disease on physical examination or on CT or bone scan.
•6. Use of finasteride, dutasteride at any point during the study.
•7. Clinically significant abnormal laboratory value \>2X the upper limit of normal (2XULN).

Locations (3)

UCLA

Los Angeles, California, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Duke University Medical Center

Durham, North Carolina, United States

Key Dates

Start Date

February 1, 2009

Primary Completion Date

April 1, 2010

Completion Date

May 1, 2012

Last Updated

August 1, 2016

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Pomegranate pill

DIETARY_SUPPLEMENT

Pomegranate pill placebo

DIETARY_SUPPLEMENT

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC