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

The study will be an 18-month, prospective, multi-center, double-blind, dose finding study with subjects who have undergone definitive treatment (surgery, cryotherapy, radiation therapy or brachytherapy) for primary prostate tumor and have had documented 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.

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.