Clinical trial · Observational
Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms, Castration-Resistant | Prostate Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Enzalutamide cohort
- description
- Patients with mCRPC initiating enzalutamide
- interventionNames
- Drug: Enzalutamide
- label
- Abiraterone cohort
- description
- Patients with mCRPC initiating abiraterone
- interventionNames
- Drug: Abiraterone acetate
Primary outcomes (1)
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available