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View Clinical Trial (Medical Research Study)

A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy - NCT00719030-27710 (Clinical Trial 343198)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy343198.aspx



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City:  Durham
State:  
NC
Zip Code: 27710
Conditions: Prostate Cancer
Purpose: 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.
Study summary: 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.
Criteria: 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 UCLA 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).
Study is available at: Duke University Medical Center
Durham, NC 27710
United States

Primary Contact:
Stephen J Freedland, MD
Email: steve.freedland@duke.edu
Phone: 919-668-8361

Secondary Contact:
Allan Pantuck, M.D.
Email: apantuck@mednet.ucla.edu
Phone: 310-206-2436
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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