Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan Injection in Metastatic Prostate Cancer: an Observational, Multicenter, Prospective Cohort Study in China (PSMAreal CN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- prostate-specific antigen (PSA) 50 response rate
研究概览
简要总结
This non-interventional, observational, multicenter, prospective cohort study is designed to investigate the treatment patterns of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan, as well as their clinical outcomes, real-world characteristics, and quality of life during the treatment period and up to one year after treatment completion.
详细描述
The study population will be divided into two cohorts, enrolling patients with mCRPC and mHSPC, respectively. Patients planned to receive lutetium (177Lu) vipivotide tetraxetan treatment according to treating physician's assessment will be enrolled in the study upon signing an informed consent form. Patients must meet all inclusion criteria defined in the protocol and not meet any exclusion criteria. The patients' medical history, prostate cancer disease characteristics, demographics, and baseline data will be collected through medical records and examination reports. Treatment patterns, treatment outcomes, and HRQoL data will be collected during study follow-up visits through patient records, examination reports, and self-reported data. This study does not have a control group; instead, a self-control method will be used, with the patients' baseline data before the start of treatment serving as the control for efficacy, safety, and HRQoL assessments. The index date for this study is defined as the date of the first administration of lutetium (177Lu) vipivotide tetraxetan
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 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male patients diagnosed with mCRPC or mHSPC Initiating lutetium (177Lu) vipivotide tetraxetan treatment by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of cycle 1 Written ICF must be obtained prior to any data collection Participants must have adequate organ function following Society of Nuclear Medicine and Molecular Imaging (SNMMI) consensus (Hope et al., 2023)
排除标准
- •Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan during the study period
- •Other protocol-defined inclusion / exclusion criteria may apply
研究组 & 干预措施
Cohort 1
Patients diagnosed with Metastatic Castration-Resistant Prostate Cancer (mCRPC) previously treated with at least one ARPI with or without taxane regimens.
Cohort 2
Patients diagnosed with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
结局指标
主要结局
prostate-specific antigen (PSA) 50 response rate
时间窗: from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visit
Defined as the proportion of patients with a confirmed decrease in PSA levels by ≥50% from baseline
prostate-specific antigen (PSA) 90 response rate
时间窗: from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visit
Defined as the proportion of patients with confirmed decreases in PSA level by ≥90% from baseline
次要结局
- Adverse events(From the index date to 1 year after the EOT visit)
- Prostate cancer disease characteristics: Baseline PET-CT results(Baseline)
- Prostate cancer disease characteristics: Baseline testosterone level(Baseline)
- Progression-Free Survival (PFS)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Time to first subsequent therapy(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Time to PSA progression(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Radiographic progression-free survival (rPFS)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Clinical PFS(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Second Progression-Free Survival (PFS2)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- OS(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Time to a first symptomatic skeletal event (SSE)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Disease control rate (DCR)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Objective response rate (ORR)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Time to response (TTR)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Duration of response (DoR)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Time to soft tissue progression (TTSTP)(Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit)
- Number of participants by treatment dose and cycles of lutetium (177Lu) vipivotide tetraxetan(Data collection of previous treatments for prostate cancer: from the time of prostate cancer diagnosis to the index date / Data collection of subsequent treatments for prostate cancer: from the index date to 1 year after the EOT visit)
- Number of participants by treatment sequences for prostate cancer(Data collection of previous treatments for prostate cancer: from the time of prostate cancer diagnosis to the index date / Data collection of subsequent treatments for prostate cancer: from the index date to 1 year after the EOT visit)
- Patient demographics and baseline characteristics(From 1 month before the index date to the index date)
- Prostate cancer disease characteristics: Number of patients with Previous prostate cancer history(Baseline)
- Prostate cancer disease characteristics: Gleason score(From 1 month before the index date to the index date)
- Prostate cancer disease characteristics: Number of patients by metastasis status(From 1 month before the index date to the index date)
- Prostate cancer disease characteristics: Number of patients by prostate cancer-related genetic mutation status(From 1 month before the index date to the index date)
- Prostate cancer disease characteristics: Baseline prostate-specific antigen (PSA) level(Baseline)
- Prostate cancer disease characteristics: prostate-specific antigen (PSA) doubling time(From 1 month before the index date to the index date)
- Prostate cancer disease characteristics: Prostate-Specific Membrane Antigen (PSMA) diagnostic drug usage(From 1 month before the index date to the index date)
- Prostate cancer disease characteristics: Baseline Eastern Cooperative Oncology Group (ECOG) performance status(Baseline)
- Prostate cancer disease characteristics: Number of patients with family history of prostate cancer(Baseline)
- Prostate cancer disease characteristics: Number of patients with carcinoembryonic Antigen (CEA)(From 1 month before the index date to the index date)
- FACT-P score(From 1 month before the index date to 1 year after the EOT visit)
- BPI-SF score(From 1 month before the index date to 1 year after the EOT visit)
- EQ-5D-5L questionnaire score(From 1 month before the index date to 1 year after the EOT visit)
- FACT-RNT score(From 1 month before the index date to 1 year after the EOT visit)