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A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer

2026年7月15日更新者：Novartis Pharmaceuticals

Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Contemporary Patients With Metastatic Castration-Resistant Prostate Cancer in the PRECISION Data Platform

The aim of this study is to assess treatment patterns, clinical outcomes, and patient characteristics among adults with metastatic castration-resistant prostate cancer (mCRPC) 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)

17111

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 confirmed mCRPC diagnosis in the US in the last 5 years who are included in the PRECISION data platform.

描述

Inclusion criteria:

Diagnosis of mCRPC between 01 January 2021 and 31 December 2025.
Male sex at index, where index is the date of initial mCRPC diagnosis.
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
mCRPC Cohort Adult male patients with a recent diagnosis of mCRPC in PRECISION.

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 Prior Therapies 大体时间：Baseline		Baseline
Number of Patients by Number of Post-index Lines of Therapy (LOTs) 大体时间：Up to approximately 5 years		Up to approximately 5 years
Number of Patients by Type of Therapy at Each LOT 大体时间：Up to approximately 5 years		Up to approximately 5 years
Percentage of Patients Switching From One Type of Therapy to Another at Each LOT 大体时间：Up to approximately 5 years		Up to approximately 5 years
Time to First-line (1L) Treatment Initiation (TTTI) 大体时间：Up to approximately 5 years	Time from index date (mCRPC diagnosis) to the start of 1L treatment.	Up to approximately 5 years
Time to Next Therapy (TTNT) for Each LOT 大体时间：Up to approximately 5 years	Time from the end of each LOT to initiation of the next LOT.	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	PFS from index date: time from mCRPC diagnosis (index date) until progression or death from any cause.	Up to approximately 5 years
PFS From Each LOT 大体时间：Up to approximately 5 years	PFS from each LOT, among those with that LOT: time from the date of initiation of the LOT 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	OS from index date: time from mCRPC diagnosis (index date) until death from any cause.	Up to approximately 5 years
OS From Each LOT 大体时间：Up to approximately 5 years	OS from each LOT, among those with that LOT: time from the date of initiation of the LOT until death from any cause.	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