A 48-Month Extension to the Randomized, Double-blind, Placebo-Controlled Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer
The primary objectives are to compare the effects of daily consumption of pomegranate liquid
extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the
end of 12,24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.
Secondary objectives are to determine the effect of the pomegranate treatment on the change
in PSA doubling time from baseline to each 12-month visit, to determine the time to tumor
recurrence, to assess the tolerability and toxicity of the pomegranate treatment and to
determine the effect of the pomegranate treatment on response rates for positive PSA
doubling times and for declining post-treatment PSA levels (negative doubling times).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.
Allan J Pantuck, MD
University of California, Los Angeles
United States: Institutional Review Board
|UCLA School of Medicine||Los Angeles, California 900121973|