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A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy
This study is currently recruiting participants.
Verified by University of California, Los Angeles, June 2008
Sponsored by: University of California, Los Angeles
Information provided by: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00719030
  Purpose

The purpose of this study is to compare the effects of pomegranate pills and a placebo (sugar pill) on prostatic oxidative. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient. Participants and their study doctor will know which study group they are in. If participants prostate cancer progresses while they are in the study, they will be withdrawn from the study. If it turns out that they are on the placebo, they will be eligible to enter into another study where they will receive the pomegranate pill.


Condition Intervention
Prostate Cancer
Dietary Supplement: Pomegranate pill
Dietary Supplement: Pomegranate pill placebo

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Placebo-Controlled, Pre-Surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Pomegranate oxidatative stress [ Time Frame: Pre-surgical ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: June 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Pomegranate pill
Dietary Supplement: Pomegranate pill
Pomegranate extract pill
2: Placebo Comparator Dietary Supplement: Pomegranate pill placebo
Pomegranate pill placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719030

Contacts
Contact: Allan Pantuck, M.D. 310-206-2436 apantuck@mednet.ucla.edu
Contact: Jean DeKernion, M.D. 310-206-6453

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Allan Pantuck     310-206-2436     apantuck@mednet.ucla.edu    
Principal Investigator: Allan Pantuck, M.D.            
Sponsors and Collaborators
University of California, Los Angeles
  More Information

Responsible Party: UCLA ( Allan Pantuck, M.D. )
Study ID Numbers: GUP-0515-02
Study First Received: July 15, 2008
Last Updated: July 17, 2008
ClinicalTrials.gov Identifier: NCT00719030  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009