Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed high-grade prostatic intraepithelial neoplasia
• •* Diagnosed within the past 6 months
• •No evidence of prostate cancer within the past 6 months
• •No evidence of palpable nodules on digital rectal exam
• •Prostate specific antigen ≤ 10 ng/mL within the past 3 months
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-1
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hepatic
• •SGOT and SGPT ≤ 1.5 times upper limit of normal
• •Renal
• •No uncontrolled renal failure
• •No cancer-related hypercalcemia or kidney stones within the past 5 years
• •Cardiovascular
• •No uncontrolled coronary artery disease
• •No uncontrolled congestive heart failure
• •Other
• •Prior malignancy allowed provided patient was curatively treated and has been disease-free for an appropriate time period for the specific cancer
• •No known HIV positivity
• •No active infection
• •No major depression or suicidal ideation
• •No other condition that would preclude study compliance
• •No other uncontrolled medical condition
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •No prior chemotherapy for any malignancy
• •Endocrine therapy
• •At least 2 weeks since prior and no concurrent finasteride (Prosear® or Propecia®) or other androgen suppressor
• •No concurrent corticosteroids
• •Radiotherapy
• •Not specified
• •Surgery
• •Not specified
• •Other
• •At least 2 weeks since prior phenytoin or phenobarbital
• •At least 2 weeks since prior ketoconazole
• •No concurrent administration of any of the following:
• •* Magnesium-containing antacids
• •* Thiazide diuretics
• •* Calcium supplements
• •* Digoxin
• •* Herbal supplements
• •* Pharmacological doses of cholecalciferol (vitamin D) or its derivatives