A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Registration Number
- NCT05968599
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 2731
- 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
- Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or immunotherapy prior to the index date
- Had a prior history of other cancers
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Enzalutamide cohort Enzalutamide Patients with mCRPC initiating enzalutamide Abiraterone cohort Abiraterone acetate Patients with mCRPC initiating abiraterone acetate
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Pfizer Inc
🇺🇸New York, New York, United States