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

July 15, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Prostatic Neoplasms, Castration-Resistant

Study Type

Observational

Enrollment (Estimated)

17111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Novartis Pharmaceuticals
Phone Number: +41613241111
Email: novartis.email@novartis.com

Study Contact Backup

Name: Novartis Pharmaceuticals

Study Locations

United States
- New Jersey
  - East Hanover, New Jersey, United States, 07936
    - Recruiting
    - Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Adult male patients with a confirmed mCRPC diagnosis in the US in the last 5 years who are included in the PRECISION data platform.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
mCRPC Cohort Adult male patients with a recent diagnosis of mCRPC in PRECISION.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients by Prior Therapies Time Frame: Baseline		Baseline
Number of Patients by Number of Post-index Lines of Therapy (LOTs) Time Frame: Up to approximately 5 years		Up to approximately 5 years
Number of Patients by Type of Therapy at Each LOT Time Frame: Up to approximately 5 years		Up to approximately 5 years
Percentage of Patients Switching From One Type of Therapy to Another at Each LOT Time Frame: Up to approximately 5 years		Up to approximately 5 years
Time to First-line (1L) Treatment Initiation (TTTI) Time Frame: 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 Time Frame: Up to approximately 5 years	Time from the end of each LOT to initiation of the next LOT.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age Time Frame: Baseline		Baseline
Number of Patients by Patient Characteristics Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria