Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)

Pfizer

Status

Completed

Conditions

Prostatic Neoplasms, Castration-Resistant

Treatments

Drug: Enzalutamide

Drug: Abiraterone acetate

Study type

Observational

Funder types

Industry

Identifiers

NCT05520138

C3431046

Enza vs Abi rwOS in Medicare (Other Identifier)

Details and patient eligibility

About

This study will be a retrospective data analysis to compare outcomes between patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) who initiated enzalutamide and those who initiated abiraterone using the 100% Fee-For-Service Medicare claims data. The study will address the following objectives:

Primary objective: To compare overall survival (OS) in patients with chemotherapy-naïve mCRPC who initiated enzalutamide vs. abiraterone

Secondary objectives:

To compare OS in patients with chemotherapy-naïve mCRPC who received only enzalutamide without any subsequent therapy vs. abiraterone without any subsequent therapy
To compare treatment duration and time to subsequent therapy in chemotherapy-naïve mCRPC patients initiating enzalutamide vs. abiraterone

Enrollment

5,506 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male with ≥ 1 diagnosis claim for prostate cancer
Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
Have initiated enzalutamide or abiraterone within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of enzalutamide or abiraterone will be defined as the index date.
Have evidence of surgical or medical castration before the index date
At least 18 years old at the index date
Continuous eligibility for ≥ 12 months prior to the index date

Exclusion criteria