Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI, Pharmaceutical / Industry ROLL-GUP-0205-1 UCLA-0507059-01, NCT00336934

Special Category: NCI Web site featured trial

Objectives

Primary

1. Evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen (PSA) levels after surgery or radiotherapy for localized prostate cancer.
2. 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

1. Assess toxicities associated with daily oral dosing of pomegranate extract in these patients.
2. 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).

Entry 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

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

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

Expected Enrollment

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

Outcomes

Objective response

Response duration
Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times

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.

Trial Contact Information

Trial Lead Organizations

Roll International Corporation

Allan Pantuck, MD, Principal investigator		Ph: 310-206-2436; 888-798-0719 Email: apantuck@mednet.ucla.edu
Arie Belldegrun, MD, FACS, Principal investigator		Ph: 310-794-6584; 888-798-0719 Email: abelldegrun@mednet.ucla.edu

U.S.A.
Alaska
	Anchorage
	Alaska Clinical Research Center, LLC
		William Clark, MD
California
	Bakersfield
	Comprehensive Blood and Cancer Center
		Ravindranath Patel, MD	Ph:  661-322-2206
	Huntington Beach
	Pacific Shores Medical Group - Huntington Beach
		Andre Liem, MD	Ph:  562-590-0345
	Long Beach
	Pacific Shores Medical Group - Long Beach
		Andre Liem, MD	Ph:  562-590-0345
	Los Alamitos
	Pacific Shores Medical Group - Los Alamitos
		Andre Liem, MD	Ph:  562-590-0345
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719
	Veterans Affairs Medical Center - West Los Angeles
		William Aronson, MD	Ph:  310-328-3446
	Santa Maria
	Central Coast Medical Oncology Corporation
		Robert Dichmann, MD	Ph:  805-349-9393
	Solvang
	Santa Barbara Hematology Oncology - Solvang
		Frederic Kass, MD	Ph:  805-686-5370
Montana
	Missoula
	Five Valleys Urology
		Garrick Simmons, MD	Ph:  406-728-3366
Nevada
	Las Vegas
		Sheldon Freedman, MD	Ph:  702-732-0282
			Email: sjfreedman@earthlink.com
New Jersey
	Lawrenceville
	AdvanceMed Research
		Gary Karlin, MD	Ph:  609-895-1991
New Mexico
	Albuquerque
	Urology Group of New Mexico
		Frederick Snoy, MD	Ph:  505-872-4090
New York
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Aaron Katz, MD	Ph:  212-305-6408
			Email: aek4@columbia.edu
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Robert Dreicer, MD, FACP	Ph:  216-445-4623
			Email: dreicer@ccf.org
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Curtis Pettaway, MD	Ph:  713-792-3250
			Email: CPettawa@mdanderson.org
Washington
	Seattle
	Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
		John Corman, MD	Ph:  206-341-0578
			Email: john.corman@vmmc.org

Related Information

Featured trial article

Registry Information
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
Trial Start Date		2005-11-29
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00336934
Date Submitted to PDQ		2006-04-07
Information Last Verified		2008-08-21
NCI Grant/Contract Number		CA16042

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