NCT07697989尚未招募不适用
Real World Clinical Effectiveness of [177Lu]Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients: A Non-Interventional Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,085
- 主要终点
- Real-World Overall Survival (rwOS)
研究概览
简要总结
This study aims to evaluate the various aspects of treatment effectiveness of [177Lu]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Patients with at least one inpatient OR two outpatient primary prostate cancer (PC) diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM]: C61) during the identification period. For outpatient diagnoses, the second confirmatory PC diagnosis must be at least 30 to 365 days after the first primary diagnosis date.
- •Patients with a metastatic diagnosis (ICD-10-CM: C77-C79) on or after the primary PC diagnosis date. The earliest metastatic diagnosis will be the patient's metastatic diagnosis date.
- •Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.
- •Patients with evidence of treatment with [177Lu]Lu-PSMA-617 after the mCRPC diagnosis date. The date of [177Lu]Lu-PSMA-617 administration will be considered as the index date.
- •Patients ≥18 years of age on metastatic diagnosis date.
- •Patients who are male.
- •Patients with at least 12 months pre-index and at least six months post-index (unless patient died) of medical history or continuous medical and pharmacy enrollment or activity (three-month allowable gap).
排除标准
- •Patients with other non-prostate primary cancer (≥ two ICD codes for one specific type of cancer in the baseline period at least 30 days apart) within three years prior to the first PC diagnosis.
- •Patients enrolled in a current clinical trial/investigational study within the 30-day period immediately prior to and including the index date or within five half-lives of the investigational product (whichever is longer) or during post-index period (ICD-10-CM: Z00.6).
- •Patients with missing age and gender information.
研究组 & 干预措施
Overall mCRPC Cohort
Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617.
Chemo-naive mCRPC Cohort
A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617 and have not received chemotherapy in the mCRPC stage.
Post-taxane mCRPC Cohort
A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of [177Lu]Lu-PSMA-617 after taxane-based chemotherapy in the mCRPC stage.
结局指标
主要结局
Real-World Overall Survival (rwOS)
时间窗: Up to approximately 3 years
rwOS, defined as the time from index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, until death due to any cause.
Median rwOS
时间窗: Up to approximately 3 years
Median rwOS, defined as the time from the index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, to when half of the patients in the cohort are still alive.
次要结局
- Baseline Demographics(Baseline)
- Proportion of Patients by Clinical Characteristic(Baseline)
- Proportion of Patients by Clinical Characteristic: Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline)
- Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status(Baseline)
- Duration Between Metastatic PC Diagnosis and mCRPC Diagnosis(Baseline)
- Prostate Specific Antigen (PSA) Level(Baseline)
- Testosterone Level(Baseline)
- Lactate Dehydrogenase (LDH) Level(Baseline)
- Alkaline Phosphatase (ALP) Level(Baseline)
- Real-World Progression Free Survival (rwPFS)(Up to approximately 3 years)
- Median rwPFS(Up to approximately 3 years)
- Duration Between mCRPC Diagnosis and [177Lu]Lu-PSMA-617 Treatment Initiation(Baseline)
- Number of Patients by Number of [177Lu]Lu-PSMA-617 Cycles Received(Up to approximately 3 years)
- Time Interval Between Two Consecutive [177Lu]Lu-PSMA-617 Cycles(Up to approximately 3 years)
- Proportion of Patients With a Dose Modification(Up to approximately 3 years)
- Time-to-First Dose Modification(Up to approximately 3 years)
- Proportion of Patients who Discontinue Treatment(Up to approximately 3 years)
- Proportion of Patients who Switch Treatment(Up to approximately 3 years)
- Time-to-Treatment Discontinuation (TTD1L)(Up to approximately 3 years)
- Time-to-Next Treatment (TTNT)(Up to approximately 3 years)
- Proportion of Patients With Adverse Events(Up to 42 days after the last dose of [177Lu]Lu-PSMA-617)
- Proportion of Patients With Safety Topics of Interest (STIs)(Up to approximately 3 years)
- Proportion of Prescriptions by Type of Specialty(Baseline, up to approximately 3 years)
- Proportion of Prescriptions by Type of Practice Setting(Baseline, up to approximately 3 years)
- Proportion of Patients by Type of Other Metastatic Prostate Cancer (mPC) Treatments Prior to [177Lu]Lu-PSMA-617 Treatment(Baseline)
- Proportion of Patients by Type of Other mPC Treatments After [177Lu]Lu-PSMA-617 Treatment(Up to approximately 3 years)
研究者
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