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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Roll International Corporation
ClinicalTrials.gov Identifier:
NCT00336934
First received: June 13, 2006
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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 Intervention
Prostate Cancer
Dietary Supplement: pomegranate juice
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Roll International Corporation:

Primary Outcome Measures:
  • Objective response [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response duration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: November 2005
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  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: NCT00336934

Sponsors and Collaborators
Roll International Corporation
Investigators
Principal Investigator: Allan Pantuck, MD Jonsson Comprehensive Cancer Center
Principal Investigator: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: MaryBethAudickas, Radiant Research - Chicago
ClinicalTrials.gov Identifier: NCT00336934     History of Changes
Other Study ID Numbers: CDR0000480402, P30CA016042, ROLL-GUP-0205-1, UCLA-0507059-01
Study First Received: June 13, 2006
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014