A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Response to dosing differences of Cisplatin from lab and scan results
研究概览
简要总结
It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of prostate cancer
- •Age 18 yrs or older
- •Able to provide written, informed consent
- •Subjects who have received docetaxel for metastatic disease are eligible if absolute neutrophil count is greater than 100 and platelet count is greater than 100,000 and their bone marrow reserve is deemed to be adequate
- •Subjects with castration resistant prostate cancer, as defined by having testosterone level of less than 50 Nano gram/dl, being treated with enzalutamide with a rise in PSA, confirmed with a repeat measurement within 1 to four weeks, or asymptomatic radiographic progression
排除标准
- •Subjects with estimated glomerular filtration rate of less than 50 ml/min
- •Subjects with hearing impairment. The treating physician may decide which subjects should not receive cisplatin based on audiometry or based on clinical judgment.
- •Subjects with grade 2 or greater neuropathy
- •Subjects who in the opinion of the treating physician could not tolerate the standard hydration before receiving cisplatin
- •Chemotherapy naïve subjects who in the opinion of the treating physician should receive docetaxel instead of enrolling on the trial and receive cisplatin
研究组 & 干预措施
Cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Response to dosing differences of Cisplatin from lab and scan results
时间窗: 2 years
Measures of response will be decline in Prostate Specific Antigen (PSA) and regression of metastases.
Toxicity observed with dosing differences of Cisplatin
时间窗: 2 years
Blood samples and physical assessments will be conducted and reviewed to determine toxicity of treatment. Toxicity would be symptoms such as ringing in the ears (tinnitus) peripheral neuropathy or lab findings such as rise in creatinine, electrolyte abnormalities such as low magnesium.
次要结局
未报告次要终点
研究者
Deepak Sahasrabudhe
Professor
University of Rochester