A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Astellas Pharma Europe Ltd.182 个研究点分布在 6 个国家目标入组 1,763 人2015年9月8日

适应症Metastatic Castration Resistant Prostate Cancer

干预措施enzalutamide

概览

阶段: 不适用
干预措施: enzalutamide
疾病 / 适应症: Metastatic Castration Resistant Prostate Cancer
发起方: Astellas Pharma Europe Ltd.
入组人数: 1763
试验地点: 182
主要终点: Time to treatment failure (TTF)
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

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.

注册库

clinicaltrials.gov

开始日期

2015年9月8日

结束日期

2019年2月8日

最后更新

去年

研究类型

Observational

性别

Male

研究者

发起方

Astellas Pharma Europe Ltd.

责任方

Sponsor

入排标准

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

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)