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
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ]

Enrollment: 25
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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: Allan Pantuck, Professor of Urology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00719030     History of Changes
Other Study ID Numbers: GUP-0515-02
Study First Received: July 15, 2008
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014