A Phase II Trial of Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 8
- 主要终点
- Radiographic progression free survival (rPFS)
研究概览
简要总结
The purpose of this study is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some people may be able to have breaks in treatment rather than having chemotherapy continuously which is the current standard of care. This study will tell us if having these treatment breaks guided by mGSTP1 can improve how people feel during treatment while still treating the prostate cancer effectively.
Docetaxel is a chemotherapy drug that is approved to treat prostate cancer and has been used for many years to treat prostate cancer like yours. Your doctor has already discussed this with you and you have both agreed that docetaxel is the best treatment for you to have at this time. You will have already started this chemotherapeutic treatment with docetaxel.
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
Arm 1: Intermittent docetaxel treatment
suspend docetaxel prior to cycle 4, recommencement based on mGSTP1 monitoring
干预措施: Docetaxel intermittent (Drug)
结局指标
主要结局
Radiographic progression free survival (rPFS)
时间窗: From enrollment until last patient has completed 2 years in follow up, on average 3.5 years
Radiographic progression free survival (rPFS) is defined as the time from enrollment (i.e. prior to cycle 4), the date of first documented progression on imaging by site investigator (PCWG3 criteria for bone lesions and RECIST 1.1 for soft tissue lesions) or death due to any cause.
次要结局
- Time on treatment holidays(From enrollment until last patient has completed 2 years in follow up, on average 3.5 years)
- Frequency of health resource utilisation(From time of consent until End of Study, on average 3.5 years)
- Overall treatment safety(From the date of signing consent on the Main study until 90 days after the last day of protocol treatment, on average 3.5 years)
- Overall survival(From enrollment until last patient has completed 2 years in follow up, on average 3.5 years)
- Overall quality of life(From enrollment until last patient has completed 2 years in follow up, on average 3.5 years)
- Fatigue(From enrollment until last patient has completed 2 years in follow up, on average 3.5 years)
- Fear of progression(From enrollment until last patient has completed 2 years in follow up, on average 3.5 years)
- Patient reported adverse events(From enrollment until last patient has completed 2 years in follow up, on average 3.5 years)
- Overall cost associated with treatment(From time of consent until End of Study, on average 3.5 years)