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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Pomegranate pill

Group Type EXPERIMENTAL

Pomegranate pill

Intervention Type DIETARY_SUPPLEMENT

Pomegranate extract pill

2

Group Type PLACEBO_COMPARATOR

Pomegranate pill placebo

Intervention Type DIETARY_SUPPLEMENT

Pomegranate pill placebo

Interventions

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Pomegranate pill

Pomegranate extract pill

Intervention Type DIETARY_SUPPLEMENT

Pomegranate pill placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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PomX POM-X placebo

Eligibility Criteria

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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.
11. Patient has not received experimental medications within the past six months.

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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No