An observational study in Prostatic Neoplasms, sponsored by Pfizer. Completed at 1 site in United States. Open to male participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Pfizer · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 3,017 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC
Drug: Novel hormonal therapy
As provided in real-world setting
Also known as: Abiraterone (Yonsa, Zytiga), Apalutamide (Erleada), Enzalutamide (Xtandi)
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.
Time frame: 2 years (retrospective data observation duration)
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.
| Milestone | Novel Hormonal Therapy |
|---|---|
| Started | 3017 |
| Completed | 3017 |
| Not completed | 0 |
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.
| Months | Novel Hormonal Therapy |
|---|---|
| Duration of NHT Treatment | 11.9 (11.4 to 12.7) |
Collected over Not applicable as adverse events and all-cause mortality were not planned to be evaluated for the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Novel Hormonal Therapy | — | — | — |
Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data was retrieved and observed in the study.
| Age, Continuous(Years) | Novel Hormonal Therapy |
|---|---|
| Mean | 76.0 ± 6.5 |
| Sex: Female, Male(Participants) | Novel Hormonal Therapy |
|---|---|
| Female | 0 |
| Male | 3017 |
| Race/Ethnicity, Customized(Participants) | Novel Hormonal Therapy |
|---|---|
| Race/Ethnicity, Customized — Non-Hispanic White | 2,475 |
| Race/Ethnicity, Customized — Black or African American | 246 |
| Race/Ethnicity, Customized — Asian/Pacific Islander | 76 |
| Race/Ethnicity, Customized — Hispanic | 96 |
| Race/Ethnicity, Customized — Other/Unknown | 124 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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