A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy
- Evaluate the effects of pomegranate extract in patients with and rising
prostate-specific antigen (PSA) levels after surgery or radiotherapy for localized
- 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
- 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
- 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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Allan Pantuck, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration