A Post Marketing Surveillance on PluvictoTM (Lutetium(177Lu) Vipivotide Tetraxetan) in South Korea; An Open-label, Non-interventional, Primary Data Collection, Multi-center, Non-comparative, Non-randomized Observational Study to Assess Safety and Effectiveness of Pluvicto in Real World Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 13
- 主要终点
- Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions
研究概览
简要总结
Post marketing study on Pluvicto in Korea
详细描述
This is open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Pluvicto in patients with mCRPC in the real-world setting in South Korea.
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Study participants eligible for inclusion in this study must meet all of the following criteria:
- •Male adult patient age ≥ 18
- •Subject who are being treated with Pluvicto or whose treatment plan is finalized and scheduled to be administered at the time of consent by physician in accordance with the approved indication in South Korea
- •Subject who provided the written informed consent prior to the study enrollment
排除标准
- •Study participants meeting any of the following criteria are not eligible for inclusion in this study:
- •Subject whose medical record is not accessible
- •Subject who is not willing to provide the informed consent
研究组 & 干预措施
Lutetium vipivotide tetraxetan
Patients prescribed with Lutetium vipivotide tetraxetan in real world practice
干预措施: Lutetium vipivotide tetraxetan (Other)
结局指标
主要结局
Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions
时间窗: Until 30 days after the last dose of Pluvicto, up to 33 months
The safety assessment will consist of occurrence status of all adverse events (AEs)/adverse drug reactions (ADRs), serious AEs (SAEs)/serious ADRs and unexpected AEs/unexpected ADRs. Safety data will be collected from all subjects over the study period. Subjects will be followed up for AEs until 30 days after the last dose of Pluvicto.
次要结局
- Radiographic progression-free survival (rPFS)(Up to 33 months)
- Objective response rate (ORR) as assessed by investigator(4th±1 week from the last dose)