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| 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 |
| 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.
|
OBJECTIVES:
Primary
Secondary
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.
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 |
DISEASE CHARACTERISTICS:
Documented rising prostate-specific antigen (PSA)
PSA doubling time > 3 months or ≤ 24 months
Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months
PATIENT CHARACTERISTICS:
No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months
PRIOR CONCURRENT THERAPY:
No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy
Contacts and 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 | |
| Principal Investigator: | Allan Pantuck, MD | Jonsson Comprehensive Cancer Center |
| Principal Investigator: | Arie Belldegrun, MD, FACS | Jonsson Comprehensive Cancer Center |
More Information
| 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 |
|
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer |
stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |