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

Study Overview
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Brief Summary
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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. .

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

Conditions
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Non-metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: Apalutamide
* Drug: Darolutamide (BAY 1841788)
* Drug: Enzalutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men diagnosed with prostate cancer. Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time Age ≥ 18 years at treatment start At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months. Exclusion Criteria: Evidence of metastatic disease before or 30 days after treatment start Prior history of other primary cancers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apalutamide<br> | Drug: Apalutamide<br>* Decision by the treating physician<br>|
| Darolutamide<br> | Drug: Darolutamide (BAY 1841788)<br>* Decision by the treating physician<br>* Other names: Nubeqa;|
| Enzalutamide<br> | Drug: Enzalutamide<br>* Decision by treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ARI treatment discontinuation |  | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for ARI treatment discontinuation |  | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 | 
| 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 | 
| Time to progression to mCRPC |  | 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 |