A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer

Pfizer

Status

Completed

Conditions

Prostatic Neoplasms, Castration-Resistant

Treatments

Drug: Abiraterone acetate

Drug: Enzalutamide

Study type

Observational

Funder types

Industry

Identifiers

NCT05968599

NCT05968599 (Registry Identifier)

C3431047

Details and patient eligibility

About

The purpose of this real-world study is to learn about the effects of 2 study medicines called enzalutamide and abiraterone used to treat metastatic castration-resistant prostate cancer (mCRPC).

Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Most prostate cancers need male sex hormones, such as testosterone, to grow. Prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels is known as "castration-resistant". Metastatic cancer is a cancer that has spread to other parts of the body.

This is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from the Flatiron Electronic Health Record (EHR) database.

The study will include patients' information from the database for men who:

Were confirmed by medical tests to have mCRPC
Started first-line treatment with enzalutamide or abiraterone (index date) for mCRPC
Had not received chemotherapy treatment before index date
Were 18 years of age or older on index date

Men who are part of this study will receive enzalutamide or abiraterone as part of their usual treatment for mCRPC.

We will compare the following between men receiving enzalutamide and men receiving abiraterone:

time from treatment start until death,
treatment duration, and
time to next treatment. This study will use patient information from the database until the end of information that is available.

Enrollment

2,731 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male with metastatic prostate cancer diagnosis and abstracted castration-resistant prostate cancer diagnosis
Initiated enzalutamide or abiraterone within 14 days prior to or after the metastatic castration-resistant prostate cancer diagnosis. The initiation date of enzalutamide or abiraterone will be defined as the index date.
At least 18 years old at the index date

Exclusion criteria

Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or immunotherapy prior to the index date
Had a prior history of other cancers