NCT00022412已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 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
- 未提供
排除标准
- 未提供
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
研究者
研究点 (12)
Loading locations...
相似试验
已完成
1 期
Calcitriol and Zoledronate in Treating Patients With Progressive Prostate CancerProstate CancerNCT00004928Memorial Sloan Kettering Cancer Center
已完成
2 期
preoperative docetaxel chemotherapy and radical prostatectomy for metastatic prostate cancerMetastatic, untreated, high-riskProstate CancerJPRN-jRCT1031180387Horie Shigeo2
终止
2 期
Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the ProstateProstate CancerNCT00084864Roswell Park Cancer Institute25
已完成
2 期
Trial of Iressa in Prostate Cancer PatientsProstate CancerNCT00265070AstraZeneca80
撤回
2 期
Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.High-risk Prostate CancerNCT06765954ImmunityBio, Inc.20