Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Registration Number
- NCT05520138
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 5506
- 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
- Received chemotherapy, novel hormonal therapy, radium-223, 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
- Primary Outcome Measures
Name Time Method Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW) 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) OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis.
- Secondary Outcome Measures
Name Time Method OS Among Participants Without Any Subsequent Therapy: IPTW 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) OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis.
Treatment Duration: IPTW 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) Treatment duration of the index treatment was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the discontinuation date. Discontinuation was defined as the earliest of 1) death, 2) last observed administration plus day of supply associated with last administration, or 3) day before the start of next line of therapy. Death, a gap of 90 days or more after the last observed prescription date + day of supply, and initiation of next line of therapy was considered as discontinuation events. Participants who did not discontinue were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability.
Time to Subsequent Therapy: IPTW 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) Time to subsequent therapy was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the start of next line of therapy. Participants who did not start a new line of therapy were censored at their last available follow-up, which was defined as the earliest of 1) death, 2) disenrollment from Medicare, and 3) end of data availability.
Trial Locations
- Locations (1)
Pfizer Inc
🇺🇸New York, New York, United States