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 ofhigh 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 showsno evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostatebiopsies (each with a minimum of 6 cores) in the 12 months prior to screening with atleast one of the biopsies occurring within 6 months prior to the screening visit. Bothbiopsies 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 ofstudy drug intake
• Agree to use an effective method of contraception, if the partner is of child-bearingage, 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%

Exclusion Criteria:

• Previous exposure to toremifene citrate
• Have evidence of prostate cancer (local, regional and/or distal metastasis)
• Have any history of other malignancies (Exceptions include non-melanoma skin cancer orother cancer that has no evidence of tumor reoccurrence 5 years after definitivetreatment).
• Have active systemic viral, bacterial, or fungal infections requiring treatment
• Have, in the judgment of the investigator, a clinically significant concurrent illnessor psychological, familial, sociological, geographical or other concomitant conditionthat would not permit adequate follow-up and compliance with the study protocol
• Concurrently being treated with other investigational agents or have participated inan investigational study within 60 days prior to screening
• Currently taking dutasteride. Subject is eligible if he stops dutasteride for a totalwashout of 90 days prior to the Screening Visit and agrees not to use dutasteride forthe duration of the study.
• Have previously taken finasteride for greater than two years
• Currently taking finasteride. Subject is eligible if he stops finasteride for a totalwashout of 30 days prior to the Screening Visit and agrees not to use finasteride forthe duration of the study.
• Currently taking testosterone or testosterone-like supplements, such asdehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for atotal washout of 30 days prior to the Screening Visit and agrees not to use theseagents for the duration of the study.
• Have a history of taking PC-SPES within the past two years.
• Currently taking herbal medicine or dietary supplements for prostate health, such asSaw Palmetto (also known as Serenoa Repens). Subject is eligible if he stops these agents for a total washout of 30 days prior to takingthe first dose of study drug and agrees not to use these agents for the duration of thestudy. 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