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%

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 or other cancer that has no evidence of tumor reoccurrence 5 years after definitive treatment).
* Have active systemic viral, bacterial, or fungal infections requiring treatment
* Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
* Concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to screening
* Currently taking dutasteride. Subject is eligible if he stops dutasteride for a total washout of 90 days prior to the Screening Visit and agrees not to use dutasteride for the 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 total washout of 30 days prior to the Screening Visit and agrees not to use finasteride for the duration of the study.
* Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit and agrees not to use these agents 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 as Saw Palmetto (also known as Serenoa Repens).

Subject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study.

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