A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- Presence of prostate intraepithelial neoplasia after 16 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •SGOT and SGPT ≤ 1.5 times upper limit of normal
- •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
- •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
- •Not specified
- •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
- •Herbal supplements
- •Pharmacological doses of cholecalciferol (vitamin D) or its derivatives
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: observation (Procedure)
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.
干预措施: calcitriol (Dietary Supplement)
Arm I
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.
干预措施: calcitriol (Dietary Supplement)
结局指标
主要结局
Presence of prostate intraepithelial neoplasia after 16 weeks
时间窗: 4 years
次要结局
未报告次要终点