Clinical trial NCT05968599: A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms, Castration-Resistant
Keywords: metastatic castration-resistant prostate cancer
mCRPC
enzalutamide
abiraterone
overall survival
OS
treatment duration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2023-08-01
Enrollment: 2731
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with chemotherapy-naïve mCRPC (aged ≥18 years) who initiated enzalutamide or abiraterone and met eligibility criteria will be included in the study. Patients will be identified from the Flatiron EHR database.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 8 years
Secondary outcomes:
measure: Overall survival among patients without subsequent therapy
timeFrame: Up to approximately 8 years
measure: Treatment duration
timeFrame: Up to approximately 8 years
measure: Time to subsequent therapy
timeFrame: Up to approximately 8 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Inc
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: