Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is
determined by the types of food you eat and also how you prepare your food. The researchers
helping conduct this study have found a potential link between AGE levels and cancer. The
purpose of this study is to see if Oligomeric Procyanidin Complex (OPC) has an effect on the
AGE levels in your blood and to see if those AGE levels have an effect on your cancer.

Inclusion Criteria

1. Confirmation of adenocarcinoma of the prostate that is documented by one of the
following: pathology report or clinic note with documented history of prostate cancer.

2. Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an
anti-androgen, with a current testosterone level documented to be <50ng/dL at
enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long
as the testosterone is documented to remain <50ng/dL for the entire duration of study
participation. Subjects who have undergone orchiectomy are also eligible.

3. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with
genomically-targeted agents, or Provenge is allowed.

4. Subjects must have adequate hematologic, renal, and hepatic function at baseline, as
follows:

- Hematology parameters: ANC >1000/mcL, platelets > 100,000/mcL, Hgb >8.0gm/dL

- Renal Function: eGFR of > 45mls/min using Cockkroft and Gault formula (see
appendix C).

- Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN

5. Able to swallow and retain oral medication

6. ECOG performance status of 0 - 2

7. Ability to sign written informed consent

8. Testosterone level <50ng/dL

Exclusion Criteria

1. Known allergy to grapes or grape seed

2. History of receiving more than 2 classes of ADT.

3. Current use of strong antioxidants (extracts from grape seed, milk thistle; pine bark,
green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large
quantities of red grapes, white button mushrooms, red wine. See section 4.7 for more
details.

4. PSA doubling time of <6 months, measured over the 3 months prior to enrollment.