Prostatic Neoplasms
Conditions
Keywords
metastatic castration-sensitive prostate cancer, mCSPC, metastatic hormone-sensitive prostate cancer, mHSPC, enzalutamide, abiraterone, treatment duration, time to next therapy
Brief summary
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines: * abiraterone, * apalutamide, * 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. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer. 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 information from National Veteran's Affairs (VA) Health Care Network. The study will include patients' information from the database for men who: * were identified to have mCSPC. * started treatment with NHT for mCSPC. * were 18 years of age or older at start of NHT. Men in this study will be taking NHT for treatment of their mCSPC. The study will explain: * how long men take the therapy. * how long it takes to start next therapy. This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male with ≥ 1 diagnosis claim for prostate cancer * Had documented secondary metastasis code on or after the initial prostate cancer diagnosis * Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 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 * ≥18 years old on index date * Continuous enrollment for at least 365 days before index date * Evidence to be castration-sensitive: * No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR * Diagnosis of hormone sensitive malignancy status within 90 days before the index date
Exclusion criteria
* Evidence of castration-resistance prior to the index date * Received other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date * Had diagnosis code indicating hormone resistance prior to the index date * A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration * Had a prior history of other cancers (except non-melanoma skin cancer) * Participation in a clinical trial during the 30 days before the index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Therapy (DOT) | From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months | DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Therapy (TTNT) | From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months | TTNT was defined as the time from the index date to the initiation date of a new therapy. Initiation of a new therapy was defined by switching to a different NHT, switching to different therapies. Participants who did not initiate a new therapy were censored at the end of data availability or death, whichever came first. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Kaplan-Meier method was used for analysis. |
Countries
United States
Participant flow
Recruitment details
Data of participants diagnosed with metastatic castration-sensitive prostate cancer (mCSPC), who initiated Novel Hormonal Therapy (NHT) \[abiraterone, apalutamide, or enzalutamide\] in first line (1L) setting, any date (index date) from 01-Jan-2020 to 31-Dec-2022 were retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Retrospective data was evaluated from 22-Nov-2023 to 23-Apr-2024 (approximately 5 months) per objectives of the study.
Participants by arm
| Arm | Count |
|---|---|
| Participant: NHT Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study. | 2,313 |
| Total | 2,313 |
Baseline characteristics
| Characteristic | Participant: NHT |
|---|---|
| Age, Customized Age 18-59 Years | 99 Participants |
| Age, Customized Age 60-69 Years | 451 Participants |
| Age, Customized Age 70-79 Years | 1206 Participants |
| Age, Customized Age Greater than or equal to (>=) 80 | 557 Participants |
| Race/Ethnicity, Customized Black | 522 Participants |
| Race/Ethnicity, Customized Hispanic | 114 Participants |
| Race/Ethnicity, Customized Other | 62 Participants |
| Race/Ethnicity, Customized Unknown | 137 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 1478 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2313 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 Therapy (DOT)
DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months).
Time frame: From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months
Population: Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participant: NHT | Duration of Therapy (DOT) | 18.5 Months |
Secondary
Time to Next Therapy (TTNT)
TTNT was defined as the time from the index date to the initiation date of a new therapy. Initiation of a new therapy was defined by switching to a different NHT, switching to different therapies. Participants who did not initiate a new therapy were censored at the end of data availability or death, whichever came first. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Kaplan-Meier method was used for analysis.
Time frame: From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months
Population: Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participant: NHT | Time to Next Therapy (TTNT) | NA Months |