Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Reduction in Serum PSA
研究概览
简要总结
This study evaluates if temsirolimus causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).
详细描述
Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need. New therapies that extend survival of patients beyond that provided by chemotherapy are needed.
The mechanisms of tumor progression to castration-resistance are unclear, but preclinical studies suggest that functional loss of the tumor suppressor gene PTEN and subsequent up-regulation of Akt, which is upstream of mTOR, may be involved in prostate cancer progression and metastasis. Based on these observations, it is hypothesized that mTOR inhibitor temsirolimus may prolong hormone sensitivity and delay disease progression in castration-resistant prostate cancer patients before antiandrogen withdrawal.
This study will assess efficacy on the basis of serum levels of PSA, an established surrogate endpoint for efficacy in prostate cancer.
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
Temsirolimus + Bicalutamide
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
干预措施: Temsirolimus (Drug)
Temsirolimus + Bicalutamide
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks
Casodex (bicalutamide) administered 50 mg/day orally (PO)
干预措施: Casodex (bicalutamide) (Drug)
结局指标
主要结局
Reduction in Serum PSA
时间窗: 12 weeks treatment, with primary outcome assessed at 16 weeks
Proportion of subjects with \> 50% drop in serum PSA as compared to baseline, assessed at 16 weeks
次要结局
未报告次要终点
研究者
Sandy Srinivas
Assoc Prof-Med Ctr Line
Stanford University