Comparing the Lutetium (177Lu) Vipivotide Tetraxetan Arm of the PSMAfore Clinical Trial to a Switch in Androgen Receptor Pathway Inhibitor (ARPI) as External Control Arm (ECA) Using a Real-world Data Source for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) After Progression on Prior ARPI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,525
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) of the TTA Group
研究概览
简要总结
The aim of this study is to assess the effectiveness of 177Lu-PSMA-617 (lutetium (177Lu) vipivotide tetraxetan) on survival in patients randomized to receive treatment following progression on one ARPI from the PSMAfore trial compared to the effectiveness of a change in ARPI treatment on survival in a real-world setting in patients with mCRPC who are taxane-naive but have progressed after a switch in ARPI.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 回顾性
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
- Had an International Classification of Diseases, 9th or 10th Revision, Clinical Modification (ICD-9-CM or ICD-10-CM) diagnosis of prostate cancer (PC) (ICD-9-CM 185x or ICD-10-CM C61x).
- Had at least two documented clinical visits, on different days, occurring on or after 01 Jan 2013.
- Included in probabilistic sample of patients queued for review via abstraction.
- Had diagnosis of metastatic disease on or after 01 Jan 2013.
- Histology was confirmed as adenocarcinoma of the prostate.
- Had confirmed mCRPC diagnosis.
- Treated with an ARPI-containing line of therapy (LOT; i.e., index therapy) in the mCRPC setting immediately after progression on one previous ARPI-containing line (in any setting, Hormone Sensitive PC or castration-resistant PC), as defined per the health research database's LOT rules and confirmed via abstraction.
- 18 years of age or older at the start of index therapy.
- Had an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0-1 within 30 days before or up to 7 days after index date, or unknown ECOG PS.
排除标准
- Female sex.
- Had evidence of untreated brain metastases.
- Had history of cardiac comorbidities, infection with hepatitis B or C, or spinal cord compression that would indicate significant risk to PSMAfore trial participation.
- Diagnosis of an active additional malignancy (i.e., other than prostate cancer).
- Evidence of biomarker status that would indicate eligibility for treatment other than ARPI, or better prognosis.
- Evidence of prior treatment with therapies that potentially affect study outcomes (e.g., radiopharmaceuticals, taxane, immunotherapy or biological therapy, clinical study drug (CSD), or 177Lu-PSMA-617).
- Had evidence of inadequate organ function.
- Had evidence of low levels of albumin (< 2.5 g/dL).
- Had evidence of a negative PSMA-PET scan.
- Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
External Control Arm (ECA)
RWD patients with mCRPC who were treated with a change in ARPI after progression on prior ARPI and before taxane treatment.
PSMAfore Trial Treatment Arm (TTA)
PSMAfore trial patients with mCRPC who were treated with 177Lu-PSMA-617 after progression on one ARPI.
PSMAfore Trial Control Arm (TCA)
PSMAfore trial patients with mCRPC who switched to a subsequent ARPI after progression on a prior ARPI.
结局指标
主要结局
Overall Survival (OS) of the TTA Group
时间窗: Up to approximately 3 years and 6 months
OS defined as time from randomization to death due to any cause.
Real-world Overall Survival (rwOS) of the ECA Group (for the Primary Measure)
时间窗: Up to approximately 7 years
rwOS is defined as the time from initiation of the index ARPI to death due to any cause.
次要结局
- OS of the TCA Group(Up to approximately 3 years and 6 months)
- rwOS of the ECA Group (for the Secondary Measure)(Up to approximately 7 years)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07843758
- 其他研究编号
- CAAA617A12004
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (12个月前)
- 研究完成日期
- (12个月前)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否