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Pomegranate Juice 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), April 2008

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00336934
  Purpose

RATIONALE: Pomegranate juice 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 juice works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: placebo
Drug: pomegranate juice
Phase III

MedlinePlus related topics:   Cancer   Prostate Cancer   Surgery  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control
Official Title:   A Randomized, Double-Blind, Placebo-Controlled Study of Pomegranate Juice for Men With Rising Prostate-Specific Antigen Levels Following Surgery or Radiation for Prostate Cancer

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 juice on prostate-specific antigen (PSA) doubling and velocity times [ Designated as safety issue: No ]

Estimated Enrollment:   250
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 juice daily.
Drug: pomegranate juice
Given orally daily.
Arm II: Placebo Comparator
Patients receive oral placebo daily.
Drug: placebo
Given orally daily.

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the effects of pomegranate juice 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 juice 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 juice in these patients.
  • Determine the effect of pomegranate juice 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 juice 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 250 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 juice
  • 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, California
Central Coast Medical Oncology Corporation     Recruiting
      Santa Maria, California, United States, 93454
      Contact: Robert A. Dichmann, MD     805-349-9393        
Central Hematology Oncology Medical Group, Incorporated - Alhambra     Recruiting
      Alhambra, California, United States, 91801
      Contact: Eddie H.L. Hu, MD     626-588-2825        
Central Hematology Oncology Medical Group, Incorporated - Pasadena     Recruiting
      Pasadena, California, United States, 91107
      Contact: Eddie H.L. Hu, MD     626-588-2825        
Comprehensive Blood and Cancer Center     Recruiting
      Bakersfield, California, United States, 93309-0633
      Contact: Ravindranath Patel, MD     661-322-2206        
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        
North Valley Hematology-Oncology Medical Group     Recruiting
      Northridge, California, United States, 91328
      Contact: Sheldon J. Davidson, MD, FACP     818-773-6363     sheljdavid@aol.com    
Pacific Shores Medical Group - Long Beach     Recruiting
      Long Beach, California, United States, 90813
      Contact: Andre Liem, MD     562-590-0345        
Veterans Affairs Medical Center - West Los Angeles     Recruiting
      Los Angeles, California, United States, 90073
      Contact: William Aronson, MD     310-328-3446        
Pacific Shores Medical Group - Los Alamitos     Recruiting
      Los Alamitos, California, United States, 90720
      Contact: Andre Liem, MD     562-590-0345        
Providence Holy Cross Cancer Center     Recruiting
      Mission Hills, California, United States, 91345
      Contact: Sheldon J. Davidson, MD, FACP     818-773-6363     sheljdavid@aol.com    
San Diego Cancer Center - Encinitas     Recruiting
      Encinitas, California, United States, 92024
      Contact: Mark J. Adler, MD     760-598-1700        
San Diego Cancer Center - Vista     Recruiting
      Vista, California, United States, 92081
      Contact: Mark J. Adler, MD     760-598-1700     mja@sdcri.org    
Sansum Medical Clinic     Recruiting
      Santa Barbara, California, United States, 93105
      Contact: Julie A. Taguchi, MD     805-898-3270     jtaguchi@sansumclinic.org    
Ventura Hematology-Oncology Specialists - Oxnard     Recruiting
      Oxnard, California, United States, 93030
      Contact: Rosemary E. McIntyre, MD     805-485-8709        
Pacific Shores Medical Group - Huntington Beach     Recruiting
      Huntington Beach, California, United States, 92648
      Contact: Andre Liem, MD     562-590-0345        
Wilshire Oncology Medical Group, Incorporated - 1250 South Sunset     Recruiting
      West Covina, California, United States, 91790
      Contact: Linda D. Bosserman, MD, FACP     909-596-5333        
Wilshire Oncology Medical Group, Incorporated - Glendora     Recruiting
      Glendora, California, United States, 91741
      Contact: Linda D. Bosserman, MD, FACP     909-596-5333        
Wilshire Oncology Medical Group, Incorporated - La Verne     Recruiting
      La Verne, California, United States, 91750
      Contact: Linda D. Bosserman, MD, FACP     919-596-5333     linda.bosserman@womgi.com    
Wilshire Oncology Medical Group, Incorporated - Pasadena     Recruiting
      Pasadena, California, United States, 91105
      Contact: Linda D. Bosserman, MD, FACP     909-596-5333        
Wilshire Oncology Medical Group, Incorporated - Pomona     Recruiting
      Pomona, California, United States, 91767-3021
      Contact: Linda D. Bosserman, MD, FACP     909-596-5333     linda.bosserman@womgi.com    
Wilshire Oncology Medical Group, Incorporated - Rancho Cucamonga     Recruiting
      Rancho Cucamonga, California, United States, 91730
      Contact: Linda D. Bosserman, MD, FACP     909-596-5333     linda.bosserman@womgi.com    
Wilshire Oncology Medical Group, Incorporated at Corona Cancer Center     Recruiting
      Corona, California, United States, 92879
      Contact: Linda D. Bosserman, MD, FACP     909-596-5333        
United States, Illinois
Midwest Prostate and Urology Health Center     Recruiting
      Chicago, Illinois, United States, 60622
      Contact: Gerald W. Chodak, MD     312-969-2989     gchodak1@aol.com    
Radiant Research - Chicago     Recruiting
      Chicago, Illinois, United States, 60610-4324
      Contact: Michael Davidson, MD     312-494-2220        
United States, Indiana
Providence Medical Group     Recruiting
      Haute Terre, Indiana, United States, 47802
      Contact: Sang Huh, MD     812-232-1418     thehuh@aol.com    
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    
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
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Allan Pantuck, MD     Jonsson Comprehensive Cancer Center    
Principal Investigator:     Arie Belldegrun, MD, FACS     Jonsson Comprehensive Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 
Featured trial article  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000480402, UCLA-0507059-01, ROLL-GUP-0205-1
First Received:   June 13, 2006
Last Updated:   May 28, 2008
ClinicalTrials.gov Identifier:   NCT00336934
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

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 03, 2008




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