Clinical trial NCT05520138: Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
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 the 100% Medicare Fee-For-Service (FFS) Data (2009-2020)
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
First posted: 2022-08-29
Enrollment: 5506
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: Patients 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 100% Fee-For-Service Medicare claims data.

Brief summary: 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


Eligibility criteria: 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:

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

Primary outcomes:
measure: Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW)
timeFrame: From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)
Secondary outcomes:
measure: OS Among Participants Without Any Subsequent Therapy: IPTW
timeFrame: From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)
measure: Treatment Duration: IPTW
timeFrame: From index date to date of discontinuation event or censoring date, whichever occurred first(from 10-Sep-2014 to 31-Dec-2020, approximately 76months); retrospective data extracted and evaluated from start date and until completion(approximately 10months)
measure: Time to Subsequent Therapy: IPTW
timeFrame: From index date to start of next line of therapy (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)
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: