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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide cohort | Patients initiating enzalutamide for mCSPC |
| |
| Apalutamide cohort | Patients initiating apalutamide for mCSPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | As provided in real-world setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment duration | Treatment duration will be defined as the time from index date to the discontinuation (i.e., addition of subsequent treatment, treatment gap of 90 days, death) of the index treatment for any reason. Patients without an event will be censored on the date of last confirmed clinical activity. | Up to approximately 65 months |
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Inclusion Criteria:
Exclusion Criteria:
Male
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Men with metastatic castration-sensitive prostate cancer who initiated apalutamide or enzalutamide and met eligibility criteria will be included in the study. Patients will be identified from the Flatiron Health electronic health records database.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer, Inc | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Apalutamide | Drug | As provided in real-world setting |
|
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
| C572045 | apalutamide |
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