Prostatic Neoplasms
Conditions
Keywords
metastatic castration-sensitive prostate cancer, mCSPC, metastatic hormone-sensitive prostate cancer, mHSPC, enzalutamide, abiraterone, treatment duration
Brief summary
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: * Were identified to have mCSPC. * Started treatment with novel hormonal therapy (index date) for mCSPC. * Were 65 years of age or older one year before index date. 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.
Interventions
As provided in real-world setting
Sponsors
Astellas Pharma Inc
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male with ≥ 1 diagnosis claim for prostate cancer * Have documented secondary metastasis code on or after the initial prostate cancer diagnosis * Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date. * Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date * ≥65 years old 12 months prior to the index date * Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death)
Exclusion criteria
* Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance * Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date * Had a prior history of other cancers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of NHT Treatment | 2 years (retrospective data observation duration) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Retrospective data were retrieved and evaluated per objectives of this observational study from 04-Oct-2023 to 18-Dec-2024 (approximately 1.2 years).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,017 |
| Total | 3,017 |
Baseline characteristics
| Characteristic | Novel Hormonal Therapy |
|---|---|
| Age, Continuous | 76.0 Years STANDARD_DEVIATION 6.5 |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Asian/Pacific Islander | 76 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Black or African American | 246 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Hispanic | 96 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Non-Hispanic White | 2,475 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Other/Unknown | 124 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3017 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 2 years (retrospective data observation duration)
Population: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data was retrieved and observed in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Novel Hormonal Therapy | Duration of NHT Treatment | 11.9 Months |