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

Prostatic Neoplasms, Castration-Resistant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05968599
• Other study ID #: C3431047
• Status: Active, not recruiting
• Start date: July 24, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• Enzalutamide
As provided in real-world setting
• Abiraterone acetate
As provided in real-world setting

Locations

Country	Name	City	State
United States	Pfizer Inc	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival (OS) will be defined as the time from the initiation of enzalutamide or abiraterone to the date of death.	Up to approximately 8 years
Secondary	Overall survival among patients without subsequent therapy	Overall survival (OS) among the subgroup of patients who received only enzalutamide without any subsequent therapy or received only abiraterone without any subsequent therapy.; OS will be defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death.	Up to approximately 8 years
Secondary	Treatment duration	Treatment duration will be defined as the time from the initiation of enzalutamide or abiraterone to the discontinuation date. Discontinuation will be defined as the earliest of 1) death, 2) last abstracted end date for enzalutamide or abiraterone, or 3) day before the start of next line of therapy.	Up to approximately 8 years
Secondary	Time to subsequent therapy	Time to subsequent therapy will be defined as the time from the initiation of enzalutamide or abiraterone to the start of next line of therapy.	Up to approximately 8 years

External Links

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