NCT07093801招募中不适用
Real-world Experience of Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, National, Multicenter, Prospective Cohort Study (PLU4REAL).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 35
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a local prospective, multicenter, long-term, non-interventional study using primary data collection to describe the routine clinical practice of patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan. The observation period will be from date of start of treatment up to a maximum of 18 months after end of treatment.
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 patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team).
- •≥ 18 years old at the time of enrollment.
- •Written informed consent must be obtained to participate to this study
- •In addition to the above-listed criteria, no other inclusion/
排除标准
- •exist other than the requirements stated in the local Summary of Product Characteristics (SmPC) and in the "Scheda di Monitoraggio AIFA", e.g., contraindications.
研究组 & 干预措施
Patients diagnosed with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan
Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team).
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: up to 18 months post-treatment
Defined as the time from date of initiation of lutetium (177Lu) vipivotide tetraxetan to the date of first documented progression by investigator assessment (radiographic progression according to the most recent version of Prostate Cancer Working Group \[PCWG\] or Response Evaluation Criteria In PSMA-PET/CT \[RECIP\] 1.0, clinical progression, Prostate Specific Antigen \[PSA\] progression) or death from any cause, whichever occurs first up to 18 months post-treatment.
次要结局
- Correlation between baseline clinical and molecular characteristics and and treatment outcomes(from baseline to up to 18 months post treatment)
- Number of patients with hospitalized infusion of lutetium (177Lu) vipivotide tetraxetan(8 months (treatment duration period))
- Number of patients with dosimetry performed(8-9 months (treatment duration period))
- Number of visits(9 months (from start of treatment to 30 days FUP period))
- Workdays lost(8-9 months (treatment duration period))
- Proportion of patients with SSE and time to event(up to 18 months post-treatment)
- Time to initiation of pain medication(from start of treatment to up to 18 months post-treatment)
- Change of pain medication(from baseline to up to 18 months post treatment)
- HRQoL - Functional Assessment of Cancer Therapy-Prostate (FACT-P)(from cycle 1 up to 18 months post treatment)
- HRQoL - Brief Pain Inventory - Short Form (BPI-SF)(from cycle 1 up to 18 months post treatment)
- HRQoL - Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT)(from cycle 1 up to 18 months post treatment)
- Second Progression-Free Survival (PFS2)(up to 18 months post-treatment)
- Overall Survival (OS)(up to 18 months post-treatment)
- Overall Response Rate (ORR)(up to 18 months post treatment)
- Duration of Response (DoR)(up to 18 months post-treatment)
- Proportion of patients with SSE and time to event(up to 18 months post-treatment)
- Time to initiation of pain medication(from start of treatment to up to 18 months post-treatment)
- Change of pain medication(from baseline to up to 18 months post treatment)
- HRQoL - Functional Assessment of Cancer Therapy-Prostate (FACT-P)(from cycle 1 up to 18 months post treatment)
- Prostate-Specific Antigen (PSA) response rates (RR)(up to 18 months post-treatment)
- HRQoL - Brief Pain Inventory - Short Form (BPI-SF)(from cycle 1 up to 18 months post treatment)
- HRQoL - Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT)(from cycle 1 up to 18 months post treatment)
- Correlation between baseline clinical and molecular characteristics and and treatment outcomes(from baseline to up to 18 months post treatment)
- Number of patients with hospitalized infusion of lutetium (177Lu) vipivotide tetraxetan(8 months (treatment duration period))
- Number of patients with dosimetry performed(8-9 months (treatment duration period))
- Number of visits(9 months (from start of treatment to 30 days FUP period))
- Workdays lost(8-9 months (treatment duration period))
研究者
研究点 (35)
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