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NCT05968599Completed

A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer

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

Source: ClinicalTrials.gov · Last updated 25 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
2731 (actual)
First submitted
21 Jul 2023
Start date
24 Jul 2023
Primary completion date
14 Feb 2025
Lead sponsor
Pfizer
NCT number
NCT05968599

What you commit to

  • Study type: Observational
  • Participants enrolled: 2731
  • From 24 Jul 2023 to the primary completion date, 14 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or immunotherapy prior to the index date

Other illness

  • Had a prior history of other cancers

Who the study is looking for

  • Male with metastatic prostate cancer diagnosis and abstracted castration-resistant prostate cancer diagnosis
  • Initiated enzalutamide or abiraterone within 14 days prior to or after the metastatic castration-resistant prostate cancer diagnosis. The initiation date of enzalutamide or abiraterone will be defined as the index date.
  • At least 18 years old at the index date

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pfizer Inc
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.