Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen 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.