A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 35
- 主要终点
- Time to treatment discontinuation
研究概览
简要总结
PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.
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
- •Willing and able to provide written informed consent;
- •18 years of age and above;
- •Documented histopathology or cytopathology of PCa, adenocarcinoma;
- •Confirmed as mCRPC;
- •Initiated olaparib + abiraterone after site activation
排除标准
- •Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation
结局指标
主要结局
Time to treatment discontinuation
时间窗: Up to 12 months
Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-exposed and NHA-naive), respectively. TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.
次要结局
- Time to first subsequent therapy(Up to 24 months)