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| ID | Type | Description | Link |
|---|---|---|---|
| Enza vs Abi rwOS in Medicare | Other Identifier | Alias Study Number |
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This study will be a retrospective data analysis to compare outcomes between patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) who initiated enzalutamide and those who initiated abiraterone using the 100% Fee-For-Service Medicare claims data. The study will address the following objectives:
Primary objective: To compare overall survival (OS) in patients with chemotherapy-naïve mCRPC who initiated enzalutamide vs. abiraterone
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide cohort | Patients with mCRPC initiating enzalutamide |
| |
| Abiraterone cohort | Patients with mCRPC initiating abiraterone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | As provided in real-world setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW) | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| OS Among Participants Without Any Subsequent Therapy: IPTW | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chemotherapy-naïve mCRPC (aged ≥18 years) who initiated enzalutamide or abiraterone and met eligibility criteria will be included in the study. Patients will be identified from the 100% Fee-For-Service Medicare claims data.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Inc | New York | New York | 10017 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Enzalutamide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW) | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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) |
For mortality: 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) of this retrospective observational study; Adverse events: Not applicable as adverse events were not planned to be collected during the study
From data source, individual participant data were not retrieved or validated. The minimum criteria for reporting an adverse event (AE) (i.e., identifiable patient, identifiable reporter, a suspect product, and event) cannot be met. Hence, adverse events were not collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Inc. | Pfizer ClinicalTrials.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2022 | Jun 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Abiraterone acetate | Drug | As provided in real-world setting |
|
|
| 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) |
| Treatment Duration: IPTW | 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. | 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) |
| Time to Subsequent Therapy: IPTW | 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. | 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) |
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.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| Secondary | OS Among Participants Without Any Subsequent Therapy: IPTW | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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) |
|
|
|
|
| Secondary | Treatment Duration: IPTW | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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) |
|
|
|
|
| Secondary | Time to Subsequent Therapy: IPTW | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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) |
|
|
|
|
| 2,523 |
| 2,911 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 2,176 | 2,595 | 0 | 0 | 0 | 0 |
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.
| D009369 |
| Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |