Trial Outcomes & Findings for Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (NCT NCT05520138)
NCT ID: NCT05520138
Last Updated: 2024-09-27
Results Overview
OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis.
COMPLETED
5506 participants
From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)
2024-09-27
Participant Flow
Data of participants- with chemotherapy naive metastatic castration-resistant prostate cancer (mCRPC), who initiated abiraterone or enzalutamide during the index period of 10 September 2014 to 31 May 2017 (approximately 33 months)- were included in this study. Data was retrieved from 100% Medicare Fee-For-Service (FFS). Retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months) of this retrospective observational study.
Participant milestones
| Measure |
Abiraterone
Participants with mCRPC who initiated abiraterone during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
Enzalutamide
Participants with mCRPC who initiated enzalutamide during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Overall Study
STARTED
|
2911
|
2595
|
|
Overall Study
COMPLETED
|
2911
|
2595
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
Baseline characteristics by cohort
| Measure |
Abiraterone
n=2911 Participants
Participants with mCRPC who initiated abiraterone during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
Enzalutamide
n=2595 Participants
Participants with mCRPC who initiated enzalutamide during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
Total
n=5506 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.4 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
78.6 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
78.5 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2911 Participants
n=5 Participants
|
2595 Participants
n=7 Participants
|
5506 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
364 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
2273 Participants
n=5 Participants
|
2012 Participants
n=7 Participants
|
4285 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
148 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Others
|
126 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section.
OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Abiraterone
n=2912 Participants
Participants with mCRPC who initiated abiraterone during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
Enzalutamide
n=2591 Participants
Participants with mCRPC who initiated enzalutamide during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW)
|
20.6 Months
Interval 19.7 to 21.4
|
22.5 Months
Interval 21.2 to 23.8
|
SECONDARY outcome
Timeframe: From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section.
OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Abiraterone
n=1168 Participants
Participants with mCRPC who initiated abiraterone during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
Enzalutamide
n=1075 Participants
Participants with mCRPC who initiated enzalutamide during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
OS Among Participants Without Any Subsequent Therapy: IPTW
|
10.6 Months
Interval 9.6 to 11.7
|
13.6 Months
Interval 12.4 to 15.1
|
SECONDARY outcome
Timeframe: From index date to date of discontinuation event or censoring date, whichever occurred first(from 10-Sep-2014 to 31-Dec-2020, approximately 76months); retrospective data extracted and evaluated from start date and until completion(approximately 10months)Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section.
Treatment duration of the index treatment was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the discontinuation date. Discontinuation was defined as the earliest of 1) death, 2) last observed administration plus day of supply associated with last administration, or 3) day before the start of next line of therapy. Death, a gap of 90 days or more after the last observed prescription date + day of supply, and initiation of next line of therapy was considered as discontinuation events. Participants who did not discontinue were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability.
Outcome measures
| Measure |
Abiraterone
n=2912 Participants
Participants with mCRPC who initiated abiraterone during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
Enzalutamide
n=2591 Participants
Participants with mCRPC who initiated enzalutamide during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Treatment Duration: IPTW
|
6.7 Months
Interval 6.3 to 7.0
|
7.4 Months
Interval 7.0 to 7.9
|
SECONDARY outcome
Timeframe: From index date to start of next line of therapy (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure after adjusting for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities, medical resource use) using IPTW. Hence, numbers are different here from those presented in participant and baseline section.
Time to subsequent therapy was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the start of next line of therapy. Participants who did not start a new line of therapy were censored at their last available follow-up, which was defined as the earliest of 1) death, 2) disenrollment from Medicare, and 3) end of data availability.
Outcome measures
| Measure |
Abiraterone
n=2912 Participants
Participants with mCRPC who initiated abiraterone during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
Enzalutamide
n=2591 Participants
Participants with mCRPC who initiated enzalutamide during the index period in real-world setting and whose data were observed in the study, were included in this reporting group.
|
|---|---|---|
|
Time to Subsequent Therapy: IPTW
|
14.5 Months
Interval 13.4 to 15.4
|
16.7 Months
Interval 15.9 to 17.8
|
Adverse Events
Abiraterone
Enzalutamide
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