A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostatic Neoplasms, Castration-Resistant. Basic parameters: 18 years — 115 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Contemporary Patients With Metastatic Castration-Resistant Prostate Cancer in the PRECISION Data Platform
Overview
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.
Primary outcome measures
- Number of Patients by Prior Therapies [Time frame: Baseline]
- Number of Patients by Number of Post-index Lines of Therapy (LOTs) [Time frame: Up to approximately 5 years]
- Number of Patients by Type of Therapy at Each LOT [Time frame: 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]
- Time to First-line (1L) Treatment Initiation (TTTI) [Time frame: Up to approximately 5 years]
- Time to Next Therapy (TTNT) for Each LOT [Time frame: Up to approximately 5 years]
Secondary outcome measures (6)
- Number of Patients by Patient Characteristics [Time frame: Baseline]
- Age [Time frame: Baseline]
- Progression-free Survival (PFS) From Index Date [Time frame: Up to approximately 5 years]
- PFS From Each LOT [Time frame: Up to approximately 5 years]
- Overall Survival (OS) From Index Date [Time frame: Up to approximately 5 years]
- OS From Each LOT [Time frame: Up to approximately 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Novartis — East Hanover
Identifiers
NCT: NCT07677254 · CAAA617A0US04