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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.
- 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.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment
pomegranate juice, placebo
Bauer Urology Clinic, LLC
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:44:12-0400
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