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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07677254

Enrollment

17111

Registered

2026-06-30

Start date

2026-06-30

Completion date

2026-11-30

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

Metastatic Castration-Resistant Prostate Cancer, Androgen Pathway Modulation-Resistant, APMR

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 115 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients by Prior Therapies	Baseline	—
Number of Patients by Number of Post-index Lines of Therapy (LOTs)	Up to approximately 5 years	—
Number of Patients by Type of Therapy at Each LOT	Up to approximately 5 years	—
Percentage of Patients Switching From One Type of Therapy to Another at Each LOT	Up to approximately 5 years	—
Time to First-line (1L) Treatment Initiation (TTTI)	Up to approximately 5 years	Time from index date (mCRPC diagnosis) to the start of 1L treatment.
Time to Next Therapy (TTNT) for Each LOT	Up to approximately 5 years	Time from the end of each LOT to initiation of the next LOT.

Secondary

Measure	Time frame	Description
Number of Patients by Patient Characteristics	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.
Age	Baseline	—
Progression-free Survival (PFS) From Index Date	Up to approximately 5 years	PFS from index date: time from mCRPC diagnosis (index date) until progression or death from any cause.
PFS From Each LOT	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.
Overall Survival (OS) From Index Date	Up to approximately 5 years	OS from index date: time from mCRPC diagnosis (index date) until death from any cause.
OS From Each LOT	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.

Countries

United States

Contacts

CONTACTNovartis Pharmaceuticals

novartis.email@novartis.com+41613241111

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results