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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06072196 | Registry Identifier | ClinicalTrials.gov |
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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 novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide.
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 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 insurance claim information from Medicare claims data.
The study will include patients' information from the database for men who:
Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel hormonal therapy cohort | Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel hormonal therapy | Drug | As provided in real-world setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of NHT Treatment | Treatment duration was defined as the time from the initial claim date of NHT (abiraterone, apalutamide, or enzalutamide) until the end of observation for any of the following reasons: (i) end of data availability (December 31, 2022), (ii) participant's date of death, (iii) day before a treatment switch, (iv) day of treatment discontinuation (a 90-day gap in days supply was considered as discontinuation). Retrospective retrieved data collected was evaluated for approximately 1.2 years of this study. Kaplan-Meier method was used for estimation. | 2 years (retrospective data observation duration) |
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Inclusion Criteria:
Exclusion Criteria:
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Men with metastatic castration-sensitive prostate cancer who initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) and met eligibility criteria will be included in the study. Patients will be identified from the 100% Fee-For-Service Medicare claims data.
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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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Retrospective data were retrieved and evaluated per objectives of this observational study from 04-Oct-2023 to 18-Dec-2024 (approximately 1.2 years).
Data for eligible participants with metastatic castration-sensitive prostate cancer (mCSPC), who initiated a novel hormonal therapy (NHT) [abiraterone or apalutamide or enzalutamide] and had its claim from 01-Jan-2020 to 31-Dec-2021 (index window) were retrieved from existing administrative data from Original Medicare.
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel Hormonal Therapy | Participants diagnosed with mCSPC and who initiated a NHT (abiraterone, apalutamide or enzalutamide) in real world setting under routine clinical practice were included. Data from these participants were observed retrospectively. No intervention was administered during this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data was retrieved and observed in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel Hormonal Therapy | Participants diagnosed with mCSPC and who initiated a NHT (abiraterone, apalutamide or enzalutamide) in real world setting under routine clinical practice were included. Data from these participants were observed retrospectively. No intervention was administered during this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of NHT Treatment | Treatment duration was defined as the time from the initial claim date of NHT (abiraterone, apalutamide, or enzalutamide) until the end of observation for any of the following reasons: (i) end of data availability (December 31, 2022), (ii) participant's date of death, (iii) day before a treatment switch, (iv) day of treatment discontinuation (a 90-day gap in days supply was considered as discontinuation). Retrospective retrieved data collected was evaluated for approximately 1.2 years of this study. Kaplan-Meier method was used for estimation. | Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data was retrieved and observed in the study. | Posted | Median | 95% Confidence Interval | Months | 2 years (retrospective data observation duration) |
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Not applicable as adverse events and all-cause mortality were not planned to be evaluated for the study
Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not planned to be evaluated (thus at risk appears "0").
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Novel Hormonal Therapy | Participants diagnosed with mCSPC and who initiated a NHT (abiraterone, apalutamide or enzalutamide) in real world setting under routine clinical practice were included. Data from these participants were observed retrospectively. No intervention was administered during this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2024 | Dec 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C089740 | abiraterone |
| D000069501 | Abiraterone Acetate |
| C572045 | apalutamide |
| C540278 | enzalutamide |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 0 |
| 0 |
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| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |