NCT06031805招募中不适用
A French Observational Longitudinal Multicenter Study of Adult Patients Treated in the Real-life Setting With Olaparib for the Treatment of Metastatic Castration Resistant Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 300
- 试验地点
- 66
- 主要终点
- Time to treatment discontinuation (TTD)
研究概览
简要总结
This French non-interventional longitudinal multicenter cohort study is conducted to study the added value of olaparib in the treatment of patients with mCRPC in the real world setting in terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus inform future clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult male patients (≥ 18 years old)
- •with metastatic castration-resistant prostate cancer,
- •who have initiated olaparib within at least, the last two months of study entry, at their physician's discretion or who have been enrolled in the funded early access program
- •who have been informed and are not opposed to their data collection --- For Patients initiated with olaparib in fEA,
- •Still alive and who have been informed verbally and/or in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician);
- •who deceased and who did not object to data collection for research purpose(s) during his or her lifetime.
排除标准
- •Patients opposed to the collection of their data
- •Patients participating in a clinical trial with an investigational prostate cancer targeted drug within 30 days prior to Olaparib initiation
结局指标
主要结局
Time to treatment discontinuation (TTD)
时间窗: Up to 36 months from olaparib initiation
TTD is defined as the time from the first day of olaparib treatment to the day that olaparib stopped for whatever reason or the date of death due to any cause, whichever comes first
Time to treatment discontinuation (TTD)
时间窗: Up to 24 months from olaparib initiation
TTD is defined as the time from the first day of olaparib treatment to the day that olaparib stopped for whatever reason or the date of death due to any cause, whichever comes first
次要结局
- Real-world Progression-free survival (rwPFS)(Up to 24 months from olaparib initiation)
- Time to first subsequent therapy (TFST)(Up to 24 months from olaparib initiation)
- Patient clinical characteristics(At the end of enrollment period (Up to 32 months ))
- Disease characteristics(At the end of enrollment period (Up to 32 months ))
- Real-world Progression-free survival 2 (rwPFS2)(Up to 24 months from olaparib initiation)
- Time to second subsequent therapy (TSST)(Up to 24 months from olaparib initiation)
- Symptomatic skeletal related events free-survival (SSEFS)(Up to 24 months from olaparib initiation)
- Physician characteristics(At the end of enrollment period (Up to 32 months ))
- Patient socio-demographic characteristics(At the end of enrollment period (Up to 32 months ))
- Treatment patterns description(At the end of enrollment period (Up to 32 months ))
- BRCA testing characteristics and patterns description(At the end of enrollment period (Up to 32 months ))
- Impact characterization of the timing of BRCA testing in relation to the therapeutic course on clinical outcomes(Up to 24 months from olaparib initiation)
- Reasons description for olaparib dosage changes, dose interruptions and treatment cessation(Up to 24 months from olaparib initiation)
- Patient socio-demographic characteristic(At the end of enrollment period (Up to 32 months ))
研究者
研究点 (66)
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