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

Study Overview
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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.

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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: Pomegranate pill
* Dietary Supplement: Pomegranate pill placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pomegranate pill | Dietary Supplement: Pomegranate pill<br>* Pomegranate extract pill<br>* Other names: PomX;|
| Placebo Comparator: 2<br> | Dietary Supplement: Pomegranate pill placebo<br>* Pomegranate pill placebo<br>* Other names: POM-X placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pomegranate oxidative stress |  | On day of prostate surgery following 4 weeks of taking POM-X or placebo. |