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

Completed

• Conditions: Non-metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: Apalutamide; Drug: Darolutamide (BAY 1841788); Drug: Enzalutamide

• Registration Number: NCT06013475
• Lead Sponsor: Bayer

Brief 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. .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Study Start: 2023-08-31
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1375

Inclusion Criteria

1. Men diagnosed with prostate cancer.
2. Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation
3. Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time
4. Age ≥ 18 years at treatment start
5. At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months.

Exclusion Criteria

1. Evidence of metastatic disease before or 30 days after treatment start
2. Prior history of other primary cancers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Apalutamide	Apalutamide	-
Darolutamide	Darolutamide (BAY 1841788)	-
Enzalutamide	Enzalutamide	-

Primary Outcome Measures

Name	Time	Method
Time to ARI treatment discontinuation	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Secondary Outcome Measures

Name	Time	Method
Proportion of patients, who switched to another ARI therapy	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Frequency of adverse events	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Dose modification of initial ARI	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Reasons for ARI treatment discontinuation	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Time to progression to mCRPC	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Trial Locations

Locations (1)

Bayer; 🇺🇸 Whippany, New Jersey, United States