Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

Inclusion Criteria

• •Give voluntary signed informed consent in accordance with institutional policies
• •Be male, aged ≥ 30 years
• •Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist
• •Have had a prostate biopsy in the last 6 months with a minimum of 10 cores that shows no evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostate biopsies (each with a minimum of 6 cores) in the 12 months prior to screening with at least one of the biopsies occurring within 6 months prior to the screening visit. Both biopsies should have no evidence of cancer as confirmed by the central pathologist
• •Have a serum PSA of ≤ 10 ng/mL
• •Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake
• •Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study and for 30 days after the last dose of study medication
• •Have adequate bone marrow, liver and renal function:
• •* White Blood Cell (WBC) Count ≥ 3,000/mm3;
• •* Platelet Count ≥ 100,000/mm3;
• •* Bilirubin ≤ 1.5 mg/dL;
• •* AST and ALT \< 2x upper limit of normal;
• •* Serum Creatinine ≤ 2.0 mg%
• •Have previously taken finasteride for greater than two years
• •Have a history of taking PC-SPES within the past two years.
• •Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa Repens).
• •Lycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day.
• •Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke
• •History of chronic hepatitis or cirrhosis