NCT00726596已完成2 期
NJ 1808: Autophagic Cell Death With Hydroxychloroquine in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy For Prostate Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Prostate-specific Antigen (PSA) Response
研究概览
简要总结
This phase II trial studies how well hydroxychloroquine works in treating patients with previously treated prostate cancer. Autophagy destroys proteins and other substances in cells and may be used by prostate cancer cells to survive. Hydroxychloroquine, which blocks autophagy, may slow the growth of and possibly kill prostate cancer cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hydroxychloroquine
Experimental
Hydroxychloroquine - 400 mg (cohort A) Hydroxychloroquine - 600 mg (cohort B)
干预措施: hydroxychloroquine (Drug)
结局指标
主要结局
Prostate-specific Antigen (PSA) Response
时间窗: 6 years
PSA response will be defined as a change in slope of at least 25%, when log (PSA) is plotted vs. time
次要结局
- Effect on Peripheral Blood Mononuclear Cell (PBMC) LC3 Expression by the Use of Hydroxychloroquine(6 years)
- Effect on PBMC Autophagic Vesicle Formation by the Use of Hydroxychloroquine(6 years)
- Expression of Beclin-1 in a Population of Patients Having Undergone Local Treatment With Prostatectomy(6 years)
- Feasibility and Safety of Administering Hydroxychloroquine in This Population of Patients. Rate of Adverse Events(6 years)
研究者
Biren Saraiya, MD
Assistant Professor of Medicine Medical Oncology
Rutgers Cancer Institute of New Jersey
研究点 (5)
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