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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00719030
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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 pill but does not have an active ingredient.

Condition or disease Intervention/treatment
Prostate Cancer Dietary Supplement: Pomegranate pill Dietary Supplement: Pomegranate pill placebo

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-controlled, Pre-surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy
Study Start Date : February 2009
Primary Completion Date : April 2010
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Pomegranate pill
Dietary Supplement: Pomegranate pill
Pomegranate extract pill
Other Name: PomX
Placebo Comparator: 2 Dietary Supplement: Pomegranate pill placebo
Pomegranate pill placebo
Other Name: POM-X placebo



Primary Outcome Measures :
  1. Pomegranate oxidative stress [ Time Frame: On day of prostate surgery following 4 weeks of taking POM-X or placebo. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719030


Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Allan J Pantuck, MD University of California, Los Angeles
Principal Investigator: Michael Carducci, MD Johns Hopkins Medical Center
Principal Investigator: Stephen J Freedland, MD Duke University

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00719030     History of Changes
Other Study ID Numbers: GUP-0515-02
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: June 2014

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases