Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00336934|
Recruitment Status : Completed
First Posted : June 15, 2006
Last Update Posted : August 15, 2011
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 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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: pomegranate juice Other: placebo||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Arm I
Patients receive oral pomegranate extract daily.
Dietary Supplement: pomegranate juice
Given orally daily.
Placebo Comparator: Arm II
Patients receive oral placebo daily.
Given orally daily.
- Objective response [ Time Frame: 12 months ]
- Response duration [ Time Frame: 12 months ]
- Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336934
|Principal Investigator:||Allan Pantuck, MD||Jonsson Comprehensive Cancer Center|
|Principal Investigator:||Arie Belldegrun, MD, FACS||Jonsson Comprehensive Cancer Center|