Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study

Inclusion Criteria: * Subject has histologically or cytologically confirmed adenocarcinoma of the prostate. * Subject has undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor. * Subject with a rising PSA post-prostatectomy may consider radiation as an alternative. If subject declines radiation, he may be considered eligible in this setting. * Subject has a rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry and defined as: * Absolute level of PSA \>0.4 ng/mL following surgery. * Absolute level of PSA \>1.5 ng/mL following radiation or cryotherapy. * Absolute level of PSA \>0.4 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, radiation + cryotherapy, etc.). * Absolute level of PSA \> nadir + 2 following neoadjuvant hormonal therapy along with external beam radiation. * Interim PSA values during the immediate pre-study interval may demonstrate a "fluctuation" including a decline; however, the study baseline PSA must have shown a rise within the pre-study 1 year period. * Study baseline PSAs must be determined within 4 weeks of study entry. * First postoperative PSA permitted if detectable. * Subject is \>18 years or age. * Subject has life expectancy of greater than 6 months. * Subject has ECOG performance status 0, 1 or 2 * Subject has testosterone level of \>150 ng/mL at screening. * Subjects has normal organ and marrow function as defined below: * leukocytes \>3,000/mcL * absolute neutrophil count \>1,500/mcL * platelets \>100,000/mcL * total bilirubin within normal limits except for Gilberts * AST(SGOT)/ALT(SGPT) \>2.5 X upper limit of normal * creatinine \> 2.5 upper limit of normal * testosterone level \>150 ng/mL * Subject agrees to abstain from other commercially available pomegranate products while participating in this study. * Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose while participating in the study. * Subject has signed a written informed consent document and agrees to comply with requirements of the study. Exclusion Criteria: * Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. * Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, herbal therapies containing estrogen) for a minimum of 1 year prior to study. * Subject has had prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product. * Subject has consumed more than two 8 ounce glasses of pomegranate juice per week over the past 2 months. * Subject has a known allergy to pomegranate juice or ellagic acid. * Subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.