NCT02471469已完成不适用
Personalizing Enzalutamide Therapy by Understanding the Relation Between the Decrease in the Expression Profile of a Panel of Preselected microRNAs, Tumor Related mRNAs and Treatment Response in Chemotherapy Naive Patients With mCRPC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Relation between biomarker response and therapeutic response
研究概览
简要总结
The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy.
Furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male patients with chemotherapy naive metastatic castration resistant prostate cancer*
- •Age at least 18 years
- •Patients from who it is possible to collect blood samples
- •Patient who are able and willing to give written informed consent prior to screening and enrollment
- •Life expectancy of > 6 months
- •Measurable disease *definition of CRPC according to EAU guidelines 2014
排除标准
- •None The study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. Therefore no strict exclusion criteria will be used in this study
结局指标
主要结局
Relation between biomarker response and therapeutic response
时间窗: 6 months
次要结局
- Relation between drug exposure, biomarker and therapeutic response(6 months)
研究者
研究点 (3)
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