Open-label Extension Study of the Effects of Pomegranate Extract on Rising PSA After Primary Therapy for Prostate Cancer

Exclusion Criteria

• •Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the subject a poor protocol candidate.
• •Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT cannot have a serum testosterone of ≤150 ng/mL at study entry.
• •Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
• •Subjects unable or unwilling to comply with protocol requirements.
• •Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
• •Serum PSA \>7.0 ng/mL (assessed at termination of the double-blind study or ET of the double-blind extension GUP-0205-1XX); at any PSA level, the subject will be excluded if determined by the investigator that the subject's continued participation would not be in their best interest).
• •Serum PSA doubling time \<13 weeks (assessed at termination of the double-blind study or ET of the double-blind extension GUP-0205-1XX)).
• •Evidence of metastatic disease on physical examination or on CT or bone scan.
• •Use of finasteride, dutasteride at any point since primary therapy or during the study.
• •Clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (\>2XULN).