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A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

2026年7月15日更新者：Novartis Pharmaceuticals

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

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.

研究概览

地位

招聘中

条件

前列腺肿瘤，去势抵抗

研究类型

观察性的

注册 (估计的)

1067

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Novartis Pharmaceuticals
电话号码：+41613241111
邮箱：novartis.email@novartis.com

研究联系人备份

姓名：Novartis Pharmaceuticals

学习地点

美国
- New Jersey
  - East Hanover、New Jersey、美国、07936
    - 招聘中
    - Novartis

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult male patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in the PRECISION data platform.

描述

Inclusion criteria:

Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.
Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.
Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.
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-617.
Age ≥18 years at index.

Exclusion criteria:

• None.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
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.
mCRPC Progression Subgroup A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment.
≥1 Subsequent Systemic Therapy Subgroup A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date 大体时间：Baseline	The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Baseline
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) 大体时间：Baseline	Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.	Baseline
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans 大体时间：Baseline up to approximately 5 years		Baseline up to approximately 5 years
Number of Patients by Timing of PSMA Scans 大体时间：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.	Baseline up to approximately 5 years
Number of Patients by Number of Post-index LOTs 大体时间：Up to approximately 5 years		Up to approximately 5 years
Number of Patients by Type of Therapy at Each Post-index LOT 大体时间：Up to approximately 5 years		Up to approximately 5 years
Time From Index Date to Next Therapy Initiation 大体时间：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.	Up to approximately 5 years

次要结果测量

结果测量	措施说明	大体时间
年龄大体时间：基线		基线
Number of Patients by Patient Characteristics 大体时间：Baseline	Patient characteristics include race, geographical region, insurance status, marital status, type of treatment center, comorbidities, Gleason score, disease stage at diagnosis, and prostate-specific antigen (PSA) level.	Baseline
Progression-free Survival (PFS) From Index Date 大体时间：Up to approximately 5 years	Time from the applicable index date until progression or death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Up to approximately 5 years
PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy 大体时间：Up to approximately 5 years	Time from the initiation of first post-index therapy until progression or death from any cause.	Up to approximately 5 years
Overall Survival (OS) From Index Date 大体时间：Up to approximately 5 years	Time from the applicable index date until death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Up to approximately 5 years
OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy 大体时间：Up to approximately 5 years	Time from initiation of first post-index therapy until death from any cause.	Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level 大体时间：Up to approximately 5 years	Reduction in PSA level categorized as follows: ≥50% (PSA50) reduction in PSA level ≥80% (PSA80) reduction in PSA level ≥90% (PSA90) 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 大体时间：Up to approximately 5 years		Up to approximately 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

调查人员

研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月30日

初级完成 (估计的)

2026年11月30日

研究完成 (估计的)

2026年11月30日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的