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.
This study is an open-label extension to the double-blind GUP-0205-1 and double-blind extension GUP-0205-1XX studies. High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from treatment failure to hormonal ablation. Eligible male subjects were previously assigned to the placebo group in the double-blind core study or the double-blind extension study 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.