Trial Outcomes & Findings for A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (NCT NCT06072196)
NCT ID: NCT06072196
Last Updated: 2025-12-31
Results Overview
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.
COMPLETED
3017 participants
2 years (retrospective data observation duration)
2025-12-31
Participant Flow
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.
Retrospective data were retrieved and evaluated per objectives of this observational study from 04-Oct-2023 to 18-Dec-2024 (approximately 1.2 years).
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
3017
|
|
Overall Study
COMPLETED
|
3017
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Baseline characteristics by cohort
| Measure |
Novel Hormonal Therapy
n=3017 Participants
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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|---|---|
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Age, Continuous
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76.0 Years
STANDARD_DEVIATION 6.5 • n=1000 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1000 Participants
|
|
Sex: Female, Male
Male
|
3017 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · Non-Hispanic White
|
2,475 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · Black or African American
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246 Participants
n=1000 Participants
|
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Race/Ethnicity, Customized
Race/Ethnicity, Customized · Asian/Pacific Islander
|
76 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · Hispanic
|
96 Participants
n=1000 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity, Customized · Other/Unknown
|
124 Participants
n=1000 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Novel Hormonal Therapy
n=3017 Participants
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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Duration of NHT Treatment
|
11.9 Months
Interval 11.4 to 12.7
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Adverse Events
Novel Hormonal Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER