REMPRO Registry A Multi-country, Multi-centre, Non-interventional, Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,920
- 试验地点
- 1
- 主要终点
- Describe the real-world treatment patterns in patients with mCRPC
研究概览
简要总结
This is a multi-country, multi-centre, retrospective, non-interventional cohort study planned to include patients diagnosed with mCRPC between 01 January 2016 and 31 December 2018, who have received at least 1 line of treatment (LOT) in the mCRPC setting, and have 12 months of follow-up data available.
详细描述
This is a multi-country, multi-centre, retrospective, non-interventional cohort study planned to include patients diagnosed with mCRPC between 01 January 2016 and 31 December 2018, who have received at least 1 line of treatment (LOT) in the mCRPC setting, and have 12 months of follow-up data available.To describe the real-world treatment patterns in patients with mCRPC
The data will be collected retrospectively between the date of diagnosis of mCRPC (index date) and the end of follow-up, i.e., until death, the last medical record entry, or the date of data extraction, whichever is the earliest. The data on different types of treatment received by the patients, sociodemographic and clinico-pathological characteristics, and healthcare utilization will be extracted from the medical records of patients (alive or deceased) into a centrally designed electronic data capture system. For the exploratory end point on real-world treatment patterns in patients with mCSPC, data on different types of treatment received by the patients, sociodemographic and clinico-pathological characteristics will be retrospectively extracted from the medical records of patients (alive or deceased) into a centrally designed electronic data capture system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 ≥18 years of age OR legal age of being an adult in the country as per local regulations
- •Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written informed consent according to the local regulations
- •Patients with a diagnosis of metastatic (stage IV) mCRPC, confirmed by either biopsy of a metastatic tumour site or by history of biopsy-proven localized disease and evidence of metastatic disease on imaging studies (which is clearly noted in hospital/clinical records) and progression on ADT alone between 01 January 2016 and 31 December 2018
- •Availability of medical records at the participating site reflecting at least one LOT received in the mCRPC setting and 12 months of follow-up from the index date (unless the patient died or was lost to follow-up within the first 12 months after diagnosis)
排除标准
- •Patients with a concomitant cancer at the time of diagnosis of mCRPC or those who are treated with any anti-cancer therapy indicated for other cancers within 6 months of diagnosis of mCRPC, except for non-metastatic non-melanoma skin cancers or in situ or benign neoplasms.
- •Patients unable to give an informed consent (unless a waiver is granted)
结局指标
主要结局
Describe the real-world treatment patterns in patients with mCRPC
时间窗: 12 Months
Dose and DoT for each regimen for each LOT, reason(s) for stopping treatment regimen in each LOT and drug-free period D
次要结局
- Demographic and clinico-pathological profile(12 Months)
- Survival outcomes associated with different treatment regimens used for mCRPC(12 Months)
- Assess the real-world effectiveness(12 Months)
- BRCA1/2 and HRRm status(12 Months)