Muscadine Plus (MPX) In Men With Prostate Cancer

Inclusion Criteria: Patients meeting the following conditions are eligible for registration and participationin the study:

1. Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
2. Subject has undergone definitive treatment (surgery, surgery with radiation therapy,cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor (priorchemotherapy is not allowed) . a. A subject with a rising PSA post-prostatectomy should consider radiation as apotentially curative alternative. If subject declines radiation or is not a candidatefor radiation, he may be considered eligible in this setting.
3. Subject has a rising PSA on a minimum of 3 time points (2 rises) within the 12 monthsprior to study initiation (this will include the PSA measurement taken at thescreening visit, but not at the baseline day 0 study visit). For purposes of calculating PSA doubling time (PSADT):
4. All PSA values used in the calculation should be ≥ 0.20 ng/ml and overall shouldfollow a rising trend;
5. Record every available PSA drawn within the last 12 months of the most recentlocal PSA;
6. The minimum requirement is 3 PSA values obtained over 3 months with a minimum of 4 weeks between measurements;
7. If there are 4 or more PSAs available, the time interval between the first andlast PSA measurements must be at least 3 months, and, there is no minimum timeinterval requirement between any two PSA measurements;
8. For radiotherapy only patients, record PSA nadir value and collection date. PSADT (PSA doubling time) must be positive according to Memorial Sloan Kettering CancerCenter Prostate Cancer Nomograms under this link:http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx
9. One of the following criteria must be met.
10. Absolute level of PSA >0.4 ng/mL following surgery. (surgery only)
11. Absolute level of PSA >0.4 ng/mL for subjects treated with multiple treatmentmodalities (e.g., surgery + radiation, surgery + cryotherapy, etc.).
12. A rise by 2 ng/mL or more above the nadir PSA will be considered the standarddefinition for biochemical failure after radiation therapy with or withouthormonal therapy. (radiation only)
13. Subject is >18 years of age.
14. Subject has life expectancy of greater than 12 months.
15. Subject has Eastern Cooperative Oncology Group performance status 0, 1 or 2
16. Subject has testosterone level of ≥1.5 ng/mL at screening.
17. Subject has normal organ and marrow function as defined below:
18. Leukocytes >3,000/microliter
19. absolute neutrophil count >1,500/microliter
20. platelets >100,000/microliter
21. total bilirubin <1.5 x upper limit of normal except for Gilberts <2.5 x upperlimit of normal
22. aspartate aminotransferase/Alanine transaminase ≤ 2.5 X upper limit of normal
23. creatinine ≤ 2.5 upper limit of normal
24. Subject agrees to abstain from other commercially available MuscadinePlus (MP)products (Vinetra, MuscadinePlus or MP capsules) while participating in this study.
25. 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 atleast 2 months prior to screening and the subject agrees not to stop or change thedose(s) while participating in the study.
26. Subject has signed a written informed consent document and agrees to comply withrequirements of the study.
27. CT or MRI chest/abdomen/pelvis and bone scan without evidence of metastatic disease asan inclusion.
28. Subject agrees to genotyping of manganese-dependent superoxide dismutase 2 (MnSOD2)gene and any genetic counseling. Only those with Alanine/Alanine SOD2 genotype will berandomized.

Exclusion Criteria: Subjects meeting the following conditions are not eligible for participation in the study:

1. Subject has known radiographic evidence of metastatic disease, except for presence ofpositive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodesless than 1.5 cm maybe considered nonspecific and the patient would be eligible. Ifthere is any clinical suspicion for metastatic disease, CT and Bone Scan must beperformed to rule out metastatic disease, within the last four months, per standard ofcare.
2. Subject has received any therapies that modulate testosterone levels (e.g., androgenablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 12months prior to study.
3. Subject has had prior or concomitant treatment with experimental drugs, high dosesteroids, or any other cancer treatment within 4 weeks prior to the first dose of thestudy product.
4. Subject has consumed any Muscadine Plus over the past 2 months.
5. Subject has a known allergy to muscadine grapes, ellagic acid or rice
6. Subject has uncontrolled concurrent illness including, but not limited to, ongoing oractive infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limitcompliance with study requirements.
7. Subject has negative PSA doubling time (negative doubling time corresponds withdecreasing PSA) Doubling time may be computed using the Sloan Kettering predictiontools posted athttp://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx