Muscadine Plus in Treating Rising PSA Levels in Men Carrying a Specific Gene Variant (Alanine/Alanine SOD2 Genotype) Following Initial Therapy for Prostate Cancer

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 (prior chemotherapy is not allowed) * A subject with a rising PSA post-prostatectomy should consider radiation as a potentially curative alternative. If subject declines radiation or is not a candidate for radiation, he may be considered eligible in this setting
• Subject has a rising PSA on a minimum of 3 time points (2 rises) within the 12 months prior to study initiation (this will include the PSA measurement taken at the screening visit, but not at the baseline day 0 study visit). The three time points must be at least 21 days apart. Note: Fluctuations in PSA are allowed per Bubley et al 1999 working group criteria.
• For purposes of calculating PSADT: * All PSA values used in the calculation should be >= 0.10 ng/ml and overall should follow a rising trend; * Record every available PSA drawn within the last 12 months; * The minimum requirement is 3 PSA values; * For radiotherapy only patients, record PSA nadir value and collection date PSADT must be positive according to Memorial Sloan Kettering Cancer Center Prostate Cancer Nomograms.
• At least 2 PSA rises need to be after a normal testosterone for those patients who had prior hormone therapy
• One of the following criteria must be met. * Absolute level of PSA > 0.2 ng/mL following surgery (surgery only) * Absolute level of PSA > 0.2 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, surgery + cryotherapy, etc.) * A rise by 2 ng/mL or more above the nadir PSA will be considered the standard definition for biochemical failure after radiation therapy with or without hormonal therapy (radiation only)
• Subject has life expectancy of greater than 12 months
• Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Subject has testosterone level of >= 150 ng/dL at screening
• Leukocytes > 3,000/mcL
• Absolute neutrophil count > 1,500/mcL
• Platelets > 100,000/mcL
• Total bilirubin =< 1.5 x upper limit of normal except for Gilberts =< 2.5 x upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X upper limit of normal
• Creatinine =< 2.5 upper limit of normal
• Subject agrees to abstain from other commercially available MuscadinePlus (MP) products (Vinetra, MPlus or MP capsules) while participating in this study
• Subject’s use of other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, acai concentrated extract, 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
• Subject has signed a written informed consent document and agrees to comply with requirements of the study
• Computed tomography (CT) or magnetic resonance imaging (MRI) chest/abdomen/pelvis and bone scan without evidence of metastatic disease as an inclusion (Chest X ray may be used instead of chest CT scan).
• Subject agrees to genotyping of MnSOD2 gene. Only those with AA genotype will be randomized

Exclusion Criteria

• Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 1.5 cm maybe considered nonspecific and the patient would be eligible (including those patients who were treated with radiation for oligometastatic disease). If there is any clinical suspicion for metastatic disease, CT and bone scan must be performed to rule out metastatic disease, within the last three months, per standard of care
• Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 12 months 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 any muscadine plus over the past 2 months
• Subject has a known allergy to muscadine grapes, ellagic acid or rice.
• Subject has uncontrolled concurrent 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
• Subject has negative PSA doubling time (negative doubling time corresponds with decreasing PSA) Doubling time may be computed using the Sloan Kettering prediction tools