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



Status:Archived
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy


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.


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.


We found this trial at
19
sites
1800 Clove Rd # 2NY
Staten Island, New York 10305
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125 Alison Dr # 2
Alexander City, Alabama 35010
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Alexander City, AL
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Huntington Beach, California 92648
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Huntington Beach, CA
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2 Princess Road
Lawrence, New Jersey 08648
609-895-0735
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Lawrence, NJ
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3791 Katella Avenue # 205
Los Alamitos, California 90720
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Los Alamitos, CA
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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Los Angeles, CA
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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Minneapolis, MN
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Missoula, Montana 59802
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Missoula, MT
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47 Santa Rosa Street, upstairs
San Luis Obispo, California 93401
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San Luis Obispo, CA
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220 S Palisade Dr # 204
Santa Maria, California 93454
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Santa Maria, CA
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Seattle, WA
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2040 Viborg Road
Solvang, California 93463
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Solvang, CA
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Anchorage, Alaska 99508
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Anchorage, AK
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Cleveland, OH
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Dallas, Texas 75216
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Dallas, TX
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Fullerton, California 92835
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Fullerton, CA
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Henderson, Nevada
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Henderson, NV
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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722 W 168th St
New York, New York 10032
(212) 305-2500
Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
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New York, NY
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