A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide

University of Rochester1 个研究点分布在 1 个国家目标入组 12 人2018年9月21日

适应症Prostate Cancer

干预措施Cisplatin

概览

阶段: 早期 1 期
干预措施: Cisplatin
疾病 / 适应症: Prostate Cancer
发起方: University of Rochester
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
状态: 已完成
最后更新: 去年

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2018年9月21日

结束日期

2023年7月31日

最后更新

去年

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

University of Rochester

责任方

Principal Investigator

主要研究者

Deepak Sahasrabudhe

Professor

University of Rochester

入排标准

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

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.