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

NCT00719030 | Completed

• 1 other identifier: GUP-0515-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Pomegranate oxidative stress

  On day of prostate surgery following 4 weeks of taking POM-X or placebo.

Study Arms (2)

1

EXPERIMENTAL

Pomegranate pill

Dietary Supplement: Pomegranate pill

2

PLACEBO COMPARATOR

Dietary Supplement: Pomegranate pill placebo

Interventions

Pomegranate pill DIETARY_SUPPLEMENT

Pomegranate extract pill

Also known as: PomX

1

Pomegranate pill placebo DIETARY_SUPPLEMENT

Pomegranate pill placebo

Also known as: POM-X placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs.
• Radical prostatectomy scheduled at Duke or Johns Hopkins.
• Initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review.
• Age ≥ 18 years of age.
• Willingness and ability to sign an informed consent document.
• Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
• No prior allergy to pomegranate dietary agents.
• No significant medical or psychiatric condition that would make the patient a poor protocol candidate.
• 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.
• The patient is not taking LHRH agonists, androgen receptor blocking agents or finasteride, and has not undergone bilateral orchiectomy.
• Patient has not received experimental medications within the past six months.

You may not qualify if:

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (3)

UCLA

Los Angeles, California, 90095, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Allan J Pantuck, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Michael Carducci, MD

  Johns Hopkins Medical Center

  PRINCIPAL INVESTIGATOR

• Stephen J Freedland, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 21, 2008
• Study Start: February 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2012
• Last Updated: August 1, 2016

Record last verified: 2014-06

Locations

US (3)