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

Completed · Not applicable · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00719030

Run by

Jonsson Comprehensive Cancer Center

People needed

25

Starts

2009-02-01

Expected to finish

2012-05-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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