Precancerous/Nonmalignant Condition, Prostate Cancer
Conditions
Keywords
prostate cancer, high grade prostatic intraepithelial neoplasia
Brief summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known whether calcitriol is more effective than observation in preventing prostate cancer. PURPOSE: This randomized phase II trial is studying how well calcitriol works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia.
Detailed description
OBJECTIVES: * Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia. * Determine the toxicity of this drug in these patients. * Determine the effect of this drug on prostate specific antigen in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms. * Arm I: Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses in the absence of unacceptable toxicity. 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 with no HGPIN or prostate cancer by biopsy are removed from the study. * Arm II: 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. Patients with no HGPIN or prostate cancer by biopsy are removed from the study. After completion of study treatment, patients are followed annually for 2 years. PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Interventions
DIETARY_SUPPLEMENTcalcitriol
Given orally
PROCEDUREobservation
No initial intervention
Sponsors
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of prostate intraepithelial neoplasia after 16 weeks | 4 years |
Countries
United States
Outcome results
None listed