An Open-label Extension Study of the Effects of Pomegranate Extract on Rising Prostate-specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer.
This study is an open-label extension to the double-blind GUP-0205-1 and double-blind
extension GUP-0205-1XX studies. Eligible male subjects, i.e.,men who had rising PSA levels
following primary therapy for localized prostate cancer, were previously assigned to the
placebo group in the double-blind study or the double-blind extension and were diagnosed
with disease progression while on placebo treatment. Upon satisfying all entry criteria, the
subjects will receive open-label pomegranate extract for up to 48 months in the absence of
further disease progression or intolerable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The within-subject difference between the PSA doubling time from the end of double-blind placebo treatment to the end of open-label pomegranate extract treatment.
Allan J Pantuck, MD
University of California, Los Angeles
United States: Institutional Review Board
|UCLA School of Medicine||Los Angeles, California 900121973|