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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05968599

Collaborator

Astellas Pharma Inc (Industry)

2,800

Enrollment

Location

Anticipated Duration (Months)

560.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms, Castration-Resistant	Drug: Enzalutamide Drug: Abiraterone acetate

Study Design

Study Type:

Observational

Anticipated Enrollment :

2800 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

A Real-World Comparison of Clinical Outcomes in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer(mCRPC) Patients Who Initiated Enzalutamide vs. Abiraterone Acetate (Abiraterone) in Flatiron Electronic Health Record (EHR) Database

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Enzalutamide cohort Patients with mCRPC initiating enzalutamide	Drug: Enzalutamide As provided in real-world setting Other Names: Xtandi
Abiraterone cohort Patients with mCRPC initiating abiraterone acetate	Drug: Abiraterone acetate As provided in real-world setting Other Names: Yonsa, Zytiga

Arm

Intervention/Treatment

Enzalutamide cohort

Patients with mCRPC initiating enzalutamide

Drug: Enzalutamide

As provided in real-world setting

Other Names:

Xtandi

Abiraterone cohort

Patients with mCRPC initiating abiraterone acetate

Drug: Abiraterone acetate

As provided in real-world setting

Other Names:

Yonsa, Zytiga

Outcome Measures

Primary Outcome Measures

Overall Survival [Up to approximately 8 years]
Overall survival (OS) will be defined as the time from the initiation of enzalutamide or abiraterone to the date of death.

Secondary Outcome Measures

Overall survival among patients without subsequent therapy [Up to approximately 8 years]
Overall survival (OS) among the subgroup of patients who received only enzalutamide without any subsequent therapy or received only abiraterone without any subsequent therapy. OS will be defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death.
Treatment duration [Up to approximately 8 years]
Treatment duration will be defined as the time from the initiation of enzalutamide or abiraterone to the discontinuation date. Discontinuation will be defined as the earliest of 1) death, 2) last abstracted end date for enzalutamide or abiraterone, or 3) day before the start of next line of therapy.
Time to subsequent therapy [Up to approximately 8 years]
Time to subsequent therapy will be defined as the time from the initiation of enzalutamide or abiraterone to the start of next line of therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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