Real-World Characteristics, Treatment Patterns, and Outcomes Among Adults With mCRPC Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,067
- 试验地点
- 1
- 主要终点
- Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date
研究概览
简要总结
The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.
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 115 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Evidence of 177Lu-PSMA-617 use on or after 01 January
- •Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-
- •Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-
- •Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-
- •Age ≥18 years at index.
排除标准
- 未提供
研究组 & 干预措施
≥1 Subsequent Systemic Therapy Subgroup
A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy.
mCRPC Progression Subgroup
A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment.
Overall mCRPC Cohort
Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION.
结局指标
主要结局
Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date
时间窗: Baseline
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC)
时间窗: Baseline
Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans
时间窗: Baseline up to approximately 5 years
Number of Patients by Timing of PSMA Scans
时间窗: Baseline up to approximately 5 years
Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Number of Patients by Number of Post-index LOTs
时间窗: Up to approximately 5 years
Number of Patients by Type of Therapy at Each Post-index LOT
时间窗: Up to approximately 5 years
Time From Index Date to Next Therapy Initiation
时间窗: Up to approximately 5 years
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
次要结局
- Number of Patients by Patient Characteristics(Baseline)
- Age(Baseline)
- Progression-free Survival (PFS) From Index Date(Up to approximately 5 years)
- PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy(Up to approximately 5 years)
- Overall Survival (OS) From Index Date(Up to approximately 5 years)
- OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy(Up to approximately 5 years)
- Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level(Up to approximately 5 years)
- Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy(Up to approximately 5 years)