CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,731 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/NCT05968599
NCT05968599N/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 Flatiron Electronic Health Record (EHR) Database

Pfizer·observational·Posted Aug 1, 2023·Updated Feb 25, 2026

In Brief

An observational study evaluating Enzalutamide and Abiraterone acetate for Prostatic Neoplasms, Castration-Resistant. Completed, enrolled 2,731 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstellas Pharma Inc

Timeline

N/ACompletedFinished
202420252026
First PostedAug 1, 2023
Enrollment StartJul 24, 2023
Primary CompletionFeb 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 2.9 years ago

Interventions

Enzalutamidedrug

As provided in real-world setting

Abiraterone acetatedrug

As provided in real-world setting