Prostate Cancer Clinical Trial
Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy
The purpose of this study is to look at the effect that the study drug OPC has on AGE levels in patients with prostate cancer.
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.
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.
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.
Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
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 Cockgroft and Gault formula (see appendix C).
Liver Function: Total bilirubin ≤ULN, AST and ALT <1.5xULN
Able to swallow and retain oral medication
ECOG performance status of 0 - 2
Ability to sign written informed consent
Testosterone level <50ng/dL
Known allergy to grapes or grape seed
History of receiving more than 2 classes of ADT.
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.
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