NCT06013475

An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,375 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones. The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .

Conditions

• Non-metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Apalutamide	Decision by the treating physician
DRUG	Darolutamide (BAY 1841788)	Decision by the treating physician
DRUG	Enzalutamide	Decision by treating physician

Timeline

• Start date: 2023-08-31
• Primary completion: 2024-06-28
• Completion: 2024-10-28
• First posted: 2023-08-28
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States