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

NCT ID: NCT05968599

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2731 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2025-02-14

Brief 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.

Conditions

Prostatic Neoplasms, Castration-Resistant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Enzalutamide cohort

Patients with mCRPC initiating enzalutamide

Enzalutamide

Intervention Type: DRUG

As provided in real-world setting

Abiraterone cohort

Patients with mCRPC initiating abiraterone acetate

Abiraterone acetate

Intervention Type: DRUG

As provided in real-world setting

Interventions

Enzalutamide

As provided in real-world setting

Intervention Type: DRUG

Abiraterone acetate

As provided in real-world setting

Intervention Type: DRUG

Other Intervention Names

Xtandi; Yonsa, Zytiga

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or immunotherapy prior to the index date
• Had a prior history of other cancers

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Inc

New York, New York, United States

Countries

United States

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3431047

To obtain contact information for a study center near you, click here.

Other Identifiers

NCT05968599

Identifier Type: REGISTRY

Identifier Source: secondary_id

C3431047

Identifier Type: -

Identifier Source: org_study_id