"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

Inclusion criteria:

• Informed consent to participate in study.

• Have had a single negative prostate biopsy within 6 months prior to enrollment instudy.

• Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or aPSA between 3.0 and 10 if over age 60.

• Ability and will to participate in study for 4 years.

Exclusion criteria:

• More than one previous negative prostate biopsy.

• History of prostate cancer.

• Previous prostate surgery.

• Inability to urinate requiring the need of a catheter during the previous 2 years.

• Any condition (other than benign prostatic hypertrophy) which may result in urinarysymptoms or changes in urine flow rate.

• Cancer within previous 5 years (other than basal or squamous cell cancers of theskin).

• Any unstable serious medical condition.

• Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.