Real-World Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients Receiving Lutetium-177 Vipivotide Tetraxetan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,247
- 试验地点
- 1
- 主要终点
- Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation
研究概览
简要总结
The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of 177Lu-PSMA-617 use on or after March 23, 2022
- •Date of initiation of 177Lu-PSMA-617 available in the data
- •Age ≥18 years at index
排除标准
- 未提供
研究组 & 干预措施
Overall 177Lu-PSMA-617 Cohort
All patients treated with 177Lu-PSMA-617.
Prior Treatment Use Cohort: ≥1 Androgen Receptor Pathway Inhibitor (ARPI) and ≥1 Taxane
Patients treated with 177Lu-PSMA-617 after at least 1 ARPI and at least 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.
Prior Treatment Use Cohort: 1 ARPI and 1 Taxane
Patients treated with 177Lu-PSMA-617 after 1 ARPI and 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.
Prior Treatment Use Cohort: Delayed
Patients with evidence of 1 ARPI and 1 taxane treatment plus at least 1 additional ARPI or taxane before 177Lu-PSMA-617 initiation. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.
Subsequent Treatment Use Cohort: Any Guideline-Recommended Treatment
Patients treated with any guideline-recommended treatment for mCRPC after 177Lu-PSMA-617 discontinuation. Guideline-recommended treatments include abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, radium-223; carboplatin, cisplatin, etoposide, and mitoxantrone.
Subsequent Treatment Use Cohort: ARPI/Taxane
Patients treated with any ARPI or taxane after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel).
Subsequent Treatment Use Cohort: ARPI
Patients treated with any ARPI after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide).
Subsequent Treatment Use Cohort: Taxane
Patients treated with any taxane after 177Lu-PSMA-617 discontinuation (i.e., cabazitaxel, docetaxel).
结局指标
主要结局
Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation
时间窗: Up to approximately 2 years
Number of Patients by Patient Characteristic
时间窗: Baseline
Patient characteristics included: * Age * Race * Marital status * Insurance status * Practice type * Physician specialty * Geographic region * Have a Gleason score ≤1 year of index * Gleason score (\<7, ≥7) * Have a prostate-specific antigen (PSA) test ≤1 year of index * PSA level (elevated, normal, unknown)
Mean PSA Level
时间窗: Baseline
Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation
时间窗: Baseline
Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation
时间窗: Up to approximately 2 years
Duration of 177Lu-PSMA-617 Treatment
时间窗: Up to approximately 2 years
次要结局
- Number and Percentage of Patients With a Reduction in PSA Level(Baseline up to approximately 2 years)