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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, October 2009
First Received: July 15, 2008   Last Updated: October 21, 2009   History of Changes
Sponsor: 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 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 Intervention
Prostate Cancer
Dietary Supplement: Pomegranate pill
Dietary Supplement: Pomegranate pill placebo

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pomegranate oxidative stress [ Time Frame: On day of prostate surgery following 4 weeks of taking POM-X or placebo. ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: February 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: February 2010 (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

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

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 Active, not recruiting
Los Angeles, California, United States, 90095
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Michael Carducci, MD     410-614-3977     carducci@jhmi.edu    
Contact: Serina King, CCRP     (410)-614-6139     sking18@jhmi.edu    
Principal Investigator: Michael Carducci, MD            
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Stephen J Freedland, MD     919-668-8361     steve.freedland@duke.edu    
Contact: Trish Creel, RN, BSN,OCN,CCRP     919-668-0635     patricia.creel@duke.edu    
Principal Investigator: Stephen J Freedland, MD            
Sponsors and Collaborators
University of California, Los Angeles
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
  More Information

No publications provided

Responsible Party: UCLA ( Allan Pantuck, M.D. )
Study ID Numbers: GUP-0515-02
Study First Received: July 15, 2008
Last Updated: October 21, 2009
ClinicalTrials.gov Identifier: NCT00719030     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 08, 2010