Metformin in Castration Resistant Prostate Cancer. A Multicenter Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- Progression-free survival (PFS) at 12 weeks
研究概览
简要总结
RATIONALE: Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells.
PURPOSE: This phase II trial is studying the safety of giving metformin hydrochloride as first-line therapy in treating patients with locally advanced or metastatic prostate cancer.
详细描述
OBJECTIVES:
- To determine the activity and safety of metformin hydrochloride as first-line therapy in patients with locally advanced or metastatic castration-resistant prostate cancer.
OUTLINE: This is a multicenter study.
Patients receive oral metformin hydrochloride twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Previously collected and post-treatment tumor tissue may be analyzed for PTEN status and PI3kinase-dependent pathway activation via immunohistochemistry. Blood samples may also be collected periodically and analyzed for biomarkers, pharmacogenetics, pharmacodynamics, pharmacokinetics.
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
Metformin
Metformin at a target dose of 2 x 1000 mg daily Until progression, unacceptable toxicity or refusal
干预措施: Metformin (Drug)
结局指标
主要结局
Progression-free survival (PFS) at 12 weeks
时间窗: at 12 weeks
PFS is defined as the absence of disease progression or death at 12 weeks after start of treatment.
次要结局
- PFS at 24 weeks(at 24 weeks)
- Clinical benefit rate(at 12 weeks and 24 weeks)
- Adverse events(from start of treatment until progression or death of any cause)
- Prostate-specific antigen (PSA) response((50% and 30%, best and at 12 weeks))
- Changes in PSA doubling time(after 12 weeks, after 24 weeks and at best PSA response)
- Tumor response of measurable disease according to RECIST v 1.1 criteria(after 12 weeks of treatment)
- Tumor assessment of bone lesions(at 12 weeks)
- Overall survival(from registration until death)