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

Inclusion Criteria:

- No evidence of disease progression while on any of the three GUP-0205 study products
(disease progression defined as > 100% increase in serum PSA [with a minimum value of
1.0 ng/mL]).

- Willingness and ability to sign an informed consent document.

- Agreement with complete abstinence from other commercially available pomegranate
products during the course of the study.

- Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) is acceptable
provided the dose has been stable during the course of the GUP-0205- 1 study.

Exclusion Criteria:

- Significant concomitant medical or psychiatric condition that, in the opinion of the
Principal Investigator, would put the subject at risk or compromise the protocol.

- 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; at any PSA
level, the subject will be excluded if determined by the Principal 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).

- 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).