CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,506 enrolled
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05520138
NCT05520138N/ACompleted

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)

Pfizer·observational·Posted Aug 29, 2022·Updated Sep 27, 2024

In Brief

An observational study evaluating Enzalutamide and Abiraterone acetate for Prostatic Neoplasms, Castration-Resistant. Completed, enrolled 5,506 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 29, 2022
Enrollment StartAug 29, 2022
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.8 years ago

Interventions

Enzalutamidedrug

As provided in real-world setting

Abiraterone acetatedrug

As provided in real-world setting