Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)

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 the 100% Medicare Fee-For-Service (FFS) Data (2009-2020)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520138
• Other study ID #: C3431046
• Secondary ID: Enza vs Abi rwOS
• Status: Completed
• Start date: August 29, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5506
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male with = 1 diagnosis claim for prostate cancer

• Have documented secondary metastasis code on or after the initial prostate cancer diagnosis

• Have initiated enzalutamide or abiraterone within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of enzalutamide or abiraterone will be defined as the index date.

• Have evidence of surgical or medical castration before the index date

• At least 18 years old at the index date

• Continuous eligibility for = 12 months prior to the index date

Exclusion Criteria:

• Received chemotherapy, novel hormonal therapy, radium-223, 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 (1)

Lead Sponsor	Collaborator
Pfizer

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 76 months
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 76 months
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 observed administration plus day of supply associated with last administration, or 3) day before the start of next line of therapy.	Up to approximately 76 months
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 76 months

External Links

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