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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allan Pantuck, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00719030
First received: July 15, 2008
Last updated: June 10, 2014
Last verified: June 2014

July 15, 2008
June 10, 2014
February 2009
April 2010   (final data collection date for primary outcome measure)
Pomegranate oxidative stress [ Time Frame: On day of prostate surgery following 4 weeks of taking POM-X or placebo. ] [ Designated as safety issue: No ]
Pomegranate oxidatative stress [ Time Frame: Pre-surgical ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00719030 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study Of the Effectiveness Of Pomegranate Pills in Men With Prostate Cancer Before Prostatectomy
A Randomized, Placebo-controlled, Pre-surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prostate Cancer
  • Dietary Supplement: Pomegranate pill
    Pomegranate extract pill
    Other Name: PomX
  • Dietary Supplement: Pomegranate pill placebo
    Pomegranate pill placebo
    Other Name: POM-X placebo
  • Experimental: 1
    Pomegranate pill
    Intervention: Dietary Supplement: Pomegranate pill
  • Placebo Comparator: 2
    Intervention: Dietary Supplement: Pomegranate pill placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2012
April 2010   (final data collection date for primary outcome measure)

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).
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00719030
GUP-0515-02
No
Allan Pantuck, University of California, Los Angeles
University of California, Los Angeles
Not Provided
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
University of California, Los Angeles
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP