NCT02495974已完成不适用
A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,763
- 试验地点
- 182
- 主要终点
- Time to treatment failure (TTF)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice
- •Germany only: Enzalutamide will be prescribed according to the current SmPC (Summary of Product Characteristics)
排除标准
- •Patients with the following will be excluded from study participation in France only:
- •Patients who have previously been treated with abiraterone acetate (Zytiga®) after docetaxel chemotherapy.
- •Patients who have previously been treated with cabazitaxel (Jevtana®)
- •Patients who have previously been treated with Xtandi®
- •Patients taking part in an interventional clinical trial
研究组 & 干预措施
Patients with mCRPC prescribed enzalutamide
Oral
干预措施: enzalutamide (Drug)
结局指标
主要结局
Time to treatment failure (TTF)
时间窗: up to 18 months
Time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.
次要结局
- Time to prostate specific antigen (PSA) progression(up to 18 months)
- PSA response(up to 18 months)
- Time to disease progression(up to 18 months)
- Overall Survival (France only)(up to 18 months)
- Treatment duration(up to 18 months)
- Reason for initiation of treatment with enzalutamide(up to 18 months)
- Reason for enzalutamide discontinuation(up to 18 months)
- Subsequent anti-neoplastic therapy for mCRPC(up to 18 months)
- Time to opiate use(up to 18 months)
- Pain assessed by Brief Pain Inventory Short Form (BPI-SF)(up to 18 months)
- Quality of life of participants assessed using EQ-5D-5L(up to 18 months)
- Quality of life of participants assessed using FACT-P(up to 18 months)
- Number of participants hospitalized(up to 18 months)
- Number of visits to health care professionals(up to 18 months)
- Safety assessed by reported adverse events(up to 18 months)
- Safety assessed by modification of treatment with enzalutamide as a response to adverse events(up to 18 months)
- Number of Deaths(up to 18 months)
研究者
研究点 (182)
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