Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

Age

18–any

Sex

MALE

Healthy volunteers

Not accepted

Histologically or cytologically confirmed adenocarcinoma of the prostate.
Undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.
Rising PSA on a minimum of 3 time points (including screening psa) within the 12 months prior to study initiation.
\> 18 years of age.
Life expectancy of greater than 6 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Testosterone level of ≥1.5 ng/mL at screening.
Adequate kidney, liver and bone marrow function
Agrees to abstain from other commercially available MP 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(s) while participating in the study.
Signed a written informed consent document and agrees to comply with requirements of the study.

Known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 2.0 cm maybe considered nonspecific and the patient would be eligible
Receipt of any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 6 months prior to study
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
Consumption of Muscadine Plus over the past 2 months
Known allergy to muscadine grapes or ellagic acid
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