Full Text View
Tabular View
No Study Results Posted
Related Studies
Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: June 13, 2006   Last Updated: July 22, 2009   History of Changes
Sponsor: Roll International Corporation
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00336934
  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 phase III 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 Phase
Prostate Cancer
Dietary Supplement: pomegranate juice
Other: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response [ Designated as safety issue: No ]

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

Estimated Enrollment: 180
Study Start Date: November 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral pomegranate extract daily.
Dietary Supplement: pomegranate juice
Given orally daily.
Arm II: Placebo Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336934

Locations
United States, Alabama
Bauer Urology Clinic, LLC Recruiting
Alexander City, Alabama, United States, 35010
Contact: Brad L. Bauer, MD     256-215-3601        
United States, Alaska
Alaska Clinical Research Center, LLC Recruiting
Anchorage, Alaska, United States, 99508
Contact: William Clark, MD     Not Available        
United States, California
Central Coast Medical Oncology Corporation Recruiting
Santa Maria, California, United States, 93454
Contact: Robert A. Dichmann, MD     805-349-9393        
Coastal Medical Research Group, Incorporated Recruiting
San Luis Obispo, California, United States, 93401
Contact: Joseph R. Kuntze, MD     805-549-7570        
St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center Recruiting
Fullerton, California, United States, 92835
Contact: Giribala Patel, MD     714-446-5900        
Pacific Shores Medical Group - Huntington Beach Recruiting
Huntington Beach, California, United States, 92648
Contact: Andre Liem, MD     562-590-0345        
Pacific Shores Medical Group - Los Alamitos Recruiting
Los Alamitos, California, United States, 90720
Contact: Andre Liem, MD     562-590-0345        
Santa Barbara Hematology Oncology - Solvang Recruiting
Solvang, California, United States, 93463
Contact: Frederic C. Kass, MD     805-686-5370        
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a     888-798-0719        
Veterans Affairs Medical Center - West Los Angeles Recruiting
Los Angeles, California, United States, 90073
Contact: William Aronson, MD     310-328-3446        
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
United States, Montana
Five Valleys Urology Recruiting
Missoula, Montana, United States, 59802
Contact: Garrick Simmons, MD     406-728-3366        
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Sheldon J. Freedman, MD     702-732-0282     sjfreedman@earthlink.com    
United States, New Jersey
AdvanceMed Research Recruiting
Lawrenceville, New Jersey, United States, 08648
Contact: Gary S. Karlin, MD     609-895-1991        
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Aaron E. Katz, MD     212-305-6408     aek4@columbia.edu    
Staten Island Urological Research, PC Recruiting
Staten Island, New York, United States, 10305
Contact: Ron S. Israeli, MD     718-720-6040        
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Robert Dreicer, MD, FACP     216-445-4623     dreicer@ccf.org    
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Curtis A. Pettaway, MD     713-792-3250     CPettawa@mdanderson.org    
United States, Washington
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: John M. Corman, MD     206-341-0578     john.corman@vmmc.org    
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: Radiant Research - Chicago ( Cecilia Belmonte )
Study ID Numbers: CDR0000480402, ROLL-GUP-0205-1, UCLA-0507059-01
Study First Received: June 13, 2006
Last Updated: July 22, 2009
ClinicalTrials.gov Identifier: NCT00336934     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009