Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Intermediate endpoint biomarker modulation
研究概览
简要总结
RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.
详细描述
OBJECTIVES:
- Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
- Assess the toxicity of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.
- Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
- Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed localized adenocarcinoma of the prostate
- •Candidate for prostatectomy
- •PATIENT CHARACTERISTICS:
- •21 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.4 mg/dL
- •AST no greater than 3 times normal
- •Creatinine no greater than 2.0 mg/dL
- •Calcium no greater than 10.2 mg/dL
- •No idiopathic urinary calcium stone disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No prior hormonal therapy for prostate cancer
- •No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins
- •Radiotherapy:
- •No prior brachytherapy or external beam radiotherapy for prostate cancer
- •See Disease Characteristics
- •At least 7 days since prior vitamin D therapy or calcium supplements
- •No other concurrent vitamin D analogues or calcium supplements
- •No concurrent magnesium-containing antacids
- •No concurrent thiazide-containing diuretics
- •No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis
排除标准
- 未提供
研究组 & 干预措施
Observation, then prostatectomy
Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
干预措施: conventional surgery (Procedure)
Doxercalciferol once daily for 28 days
Dietary supplement once daily to treat prostate cancer for 28 days
干预措施: doxercalciferol (Dietary Supplement)
结局指标
主要结局
Intermediate endpoint biomarker modulation
时间窗: 18 months
Toxicity
时间窗: 30 months
次要结局
未报告次要终点