Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
Precancerous/Nonmalignant Condition, Prostate Cancer
About this trial
This is an interventional prevention trial for Precancerous/Nonmalignant Condition focused on measuring prostate cancer, high grade prostatic intraepithelial neoplasia
Eligibility 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
Sites / Locations
- Central Jersey Oncology Center, PA - East Brunswick
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Saint Peter's University Hospital
- Overlook Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Arm I
Arm II
Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses. After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol.
Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I.