A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
NCT ID: NCT07086651
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1300 participants
OBSERVATIONAL
2025-07-21
2025-10-31
Brief Summary
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Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.
This is a real-world study, not a clinical study. 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 cancer clinics (Flatiron Health electronic health records).
The study will include patients' information from the database for men who:
* Were identified to have mCSPC.
* Started treatment with apalutamide or enzalutamide (index date) for mCSPC.
* Were 18 years of age or older on the index date. Men in this study will be taking apalutamide or enzalutamide for treatment of their mCSPC. The study will compare how long men take apalutamide or enzalutamide. This study will use patient information from cancer clinics. Information from start of apalutamide or enzalutamide treatment until information is available in the database will be used to describe how long patients receive treatment.
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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 initiating enzalutamide for mCSPC
Enzalutamide
As provided in real-world setting
Apalutamide cohort
Patients initiating apalutamide for mCSPC
Apalutamide
As provided in real-world setting
Interventions
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Enzalutamide
As provided in real-world setting
Apalutamide
As provided in real-world setting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initiated apalutamide or enzalutamide for the first-line treatment of metastatic castration-sensitive prostate cancer (mCSPC). Initiation date of first treatment defines the index date.
* Index date on or after 1 January 2020
* Evidence of androgen deprivation therapy (ADT) use between 90 days prior to the index date and 6 months following the index date
* Age ≥18 years on the index date -≥6 months of clinical activity following the index date, unless the patient died
Exclusion Criteria
* Received chemotherapy, androgen receptor pathway inhibitor, radiopharmaceuticals, immunotherapy, PARP inhibitor, or estrogens prior to the index date
* Evidence of ADT use between 1 year and 91 days prior to the index date
* Had a prior history of other cancers
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
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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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3431053
Identifier Type: -
Identifier Source: org_study_id
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