Safety and Efficacy of POMx in Men With Prostate Cancer: An 18-Month, Randomized, Double-Blind, Dose-Finding Study of the Effects of Two (2) Doses of Pomegranate Juice Extract Capsules (1 or 3 Capsules/Day) on Rising Prostate Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
- 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
- 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.
- 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
- 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.