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Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer

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. Identifier: NCT00336934
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : August 15, 2011
National Cancer Institute (NCI)
Information provided by:
Roll International Corporation

Brief Summary:

RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized prostate cancer.

PURPOSE: This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: pomegranate juice Other: placebo Not Applicable

Detailed Description:



  • Evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen (PSA) levels after surgery or radiotherapy for localized prostate cancer.
  • Determine the effect of a daily oral dose of pomegranate extract on the absolute value of PSA and on the change in PSA doubling time in these patients.


  • Assess toxicities associated with daily oral dosing of pomegranate extract in these patients.
  • Determine the effect of pomegranate extract on positive PSA doubling-time outcome, defined as greater than 150% baseline or a negative post-treatment PSA doubling time (i.e., declining PSA).

OUTLINE: This is a multicenter, double-blind, placebo-controlled, randomized study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral pomegranate extract daily.
  • Arm II: Patients receive oral placebo daily. Treatment in both arms continues for up to 1 year in the absence of disease progression.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy
Study Start Date : November 2005
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm I
Patients receive oral pomegranate extract daily.
Dietary Supplement: pomegranate juice
Given orally daily.

Placebo Comparator: Arm II
Patients receive oral placebo daily.
Other: placebo
Given orally daily.

Primary Outcome Measures :
  1. Objective response [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Response duration [ Time Frame: 12 months ]
  2. Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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


  • Histologically confirmed adenocarcinoma of the prostate
  • Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor
  • Documented rising prostate-specific antigen (PSA)

    • Absolute level of PSA > 0.2 ng/mL after surgery
    • Absolute level of PSA > 1.0 ng/mL after radiation or cryotherapy
    • Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy)
    • PSA must be ≥ 100% above best nadir achieved
    • PSA doubling time > 3 months or ≤ 24 months

      • Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months

        • The interval between PSA time points must be > 2 weeks
  • PSA ≤ 7.0 ng/mL
  • Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible
  • Gleason score ≤ 7
  • No histologically positive lymph nodes
  • No evidence of metastatic disease by physical examination, CT scan, or bone scan


  • Life expectancy ≥ 6 months
  • ECOG performance status 0 or 1
  • No significant concomitant medical or psychiatric conditions that would limit study compliance
  • No known allergies to pomegranate extract
  • No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months

    • Diabetic patients entering study who have not had hemoglobin A_1c level measured in the past 3 months must have levels measured at study initiation
  • No clinically abnormal laboratory values > 2 times the upper limit of normal


  • See Disease Characteristics
  • More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment
  • No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy

    • Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL
  • No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer
  • No finasteride or dutasteride at any time point after primary therapy and during study therapy
  • No other concurrent commercial pomegranate products
  • No other concurrent systemic or local therapy for prostate cancer
  • Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy

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 identifier (NCT number): NCT00336934

Sponsors and Collaborators
Roll International Corporation
National Cancer Institute (NCI)
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Principal Investigator: Allan Pantuck, MD Jonsson Comprehensive Cancer Center
Principal Investigator: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
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Responsible Party: MaryBethAudickas, Radiant Research - Chicago Identifier: NCT00336934    
Obsolete Identifiers: NCT00413530
Other Study ID Numbers: CDR0000480402
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2006    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011
Keywords provided by Roll International Corporation:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases