Status:
COMPLETED
A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 pi...
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 Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00719030
Start Date
February 1 2009
End Date
May 1 2012
Last Update
August 1 2016
Active Locations (3)
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1
UCLA
Los Angeles, California, United States, 90095
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
3
Duke University Medical Center
Durham, North Carolina, United States, 27710