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)
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| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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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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| Study summary: |
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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. |
| 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). |
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| Study is available at: |
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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 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
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