Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT ID: NCT05520138
Last Updated: 2024-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
5506 participants
OBSERVATIONAL
2022-08-29
2023-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Enzalutamide cohort
Patients with mCRPC initiating enzalutamide
Enzalutamide
As provided in real-world setting
Abiraterone cohort
Patients with mCRPC initiating abiraterone
Abiraterone acetate
As provided in real-world setting
Interventions
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Enzalutamide
As provided in real-world setting
Abiraterone acetate
As provided in real-world setting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Had a prior history of other cancers
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Inc
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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Enza vs Abi rwOS in Medicare
Identifier Type: OTHER
Identifier Source: secondary_id
C3431046
Identifier Type: -
Identifier Source: org_study_id
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