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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05968599 | Registry Identifier | ClinicalTrials.gov |
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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The purpose of this real-world study is to learn about the effects of 2 study medicines called enzalutamide and abiraterone used to treat metastatic castration-resistant prostate cancer (mCRPC).
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Most prostate cancers need male sex hormones, such as testosterone, to grow. Prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels is known as "castration-resistant". Metastatic cancer is a cancer that has spread to other parts of the body.
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 the Flatiron Electronic Health Record (EHR) database.
The study will include patients' information from the database for men who:
Men who are part of this study will receive enzalutamide or abiraterone as part of their usual treatment for mCRPC.
We will compare the following between men receiving enzalutamide and men receiving abiraterone:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide cohort | Patients with mCRPC initiating enzalutamide |
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| Abiraterone cohort | Patients with mCRPC initiating abiraterone acetate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | As provided in real-world setting |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS): Adjusted Using Inverse Probability Treatment Weighting (IPTW) | OS 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 during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Kaplan-Meier (weighted) method was used for analysis. | From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS Without Subsequent Therapy: Adjusted Using IPTW | OS 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 during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. OS of only those participants who initiated abiraterone and enzalutamide on the index date and did not receive subsequent systemic anti-neoplastic therapy were reported in this outcome measure. Kaplan-Meier (weighted) method was used for analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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Men 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 Flatiron EHR database.
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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 | 10001 | 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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Retrospective data were retrieved and evaluated per objectives of this observational study from 24-Jul-2023 to 14-Feb-2025 (approximately 18.7 months).
Data of eligible participants with metastatic castration-resistant prostate cancer (mCRPC), who initiated abiraterone or enzalutamide from 10-Sep-2014 to 30-Jun-2020 (approximately 69.7 months = index period) were retrieved from Flatiron electronic health record (EHR) database from 10-Sep-2014 to 31-May-2023 (approximately 104.7 months = data collection period).
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone | Participants diagnosed with mCRPC who initiated abiraterone, in real-world setting under routine clinical practice were included. Data from these participants were observed retrospectively. No intervention was administered during this study. |
| FG001 | Enzalutamide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 12, 2023 |
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| Abiraterone acetate | Drug | As provided in real-world setting |
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| From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
| Time to Treatment Discontinuation (TTD): Adjusted Using 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. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Discontinuation was defined as the earliest of 1) death, 2) abstracted end date for last enzalutamide or abiraterone drug episode that started within the index treatment line of therapy (LOT) (drug episodes for abstracted oral therapies from the Flatiron Drug Episode table), or 3) day before the start of next LOT. Participants who did not discontinue were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Kaplan-Meier (weighted) method was used for analysis. | From index date to date of treatment discontinuation or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
| Time to Subsequent Therapy (TTST): Adjusted Using IPTW | TTST was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the start of next LOT. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Participants who did not start a new LOT were censored at their last available follow-up, which was defined as the earliest of 1) death, 2) end of data availability or 3) last participant contact. Kaplan-Meier (weighted) method was used for analysis. | From index date to date of start of next LOT or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
Participants diagnosed with mCRPC who initiated 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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Analysis population included all eligible participants who met inclusion/exclusion criteria, whose medical records were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone | Participants diagnosed with mCRPC who initiated abiraterone, in real-world setting under routine clinical practice were included. Data from these participants were observed retrospectively. No intervention was administered during this study. |
| BG001 | Enzalutamide | Participants diagnosed with mCRPC who initiated 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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): Adjusted Using Inverse Probability Treatment Weighting (IPTW) | OS 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 during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Kaplan-Meier (weighted) method was used for analysis. | Analysis population included all participants included in this study, and were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo set was derived. Hence, numbers reported against "Overall Number of Participants Analyzed" (N) for both the arms differ from the unadjusted (raw) numbers presented in participant flow and baseline characteristics section. | Posted | Median | 95% Confidence Interval | Months | From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
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| Secondary | OS Without Subsequent Therapy: Adjusted Using IPTW | OS 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 during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. OS of only those participants who initiated abiraterone and enzalutamide on the index date and did not receive subsequent systemic anti-neoplastic therapy were reported in this outcome measure. Kaplan-Meier (weighted) method was used for analysis. | Analysis population included a sub-set of participants included in this study, who did not receive subsequent systemic anti-neoplastic therapy. The evaluable number of participants for this outcome were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo sub-set was derived. Here, 'N' signifies participants evaluable for this outcome measure after applying ITPW. | Posted | Median | 95% Confidence Interval | Months | From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
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| Secondary | Time to Treatment Discontinuation (TTD): Adjusted Using 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. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Discontinuation was defined as the earliest of 1) death, 2) abstracted end date for last enzalutamide or abiraterone drug episode that started within the index treatment line of therapy (LOT) (drug episodes for abstracted oral therapies from the Flatiron Drug Episode table), or 3) day before the start of next LOT. Participants who did not discontinue were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Kaplan-Meier (weighted) method was used for analysis. | Analysis population included all participants included in this study, and were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo set was derived. Hence, numbers reported against "Overall Number of Participants Analyzed" for both the arms differ from the unadjusted (raw) numbers presented in participant flow and baseline characteristics section. | Posted | Median | 95% Confidence Interval | Months | From index date to date of treatment discontinuation or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
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| Secondary | Time to Subsequent Therapy (TTST): Adjusted Using IPTW | TTST was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the start of next LOT. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Participants who did not start a new LOT were censored at their last available follow-up, which was defined as the earliest of 1) death, 2) end of data availability or 3) last participant contact. Kaplan-Meier (weighted) method was used for analysis. | Analysis population included all participants included in this study, and were adjusted for baseline confounders (demographics, clinical characteristics, prior treatments, comorbidities) using IPTW method. As numbers were adjusted using IPTW, pseudo set was derived. Hence, numbers reported against "Overall Number of Participants Analyzed" for both the arms differ from the unadjusted (raw) numbers presented in participant flow and baseline characteristics section. | Posted | Median | 95% Confidence Interval | Months | From index date to date of start of next LOT or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months |
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All-cause mortality: During Data collection period of approximately 104.7 months; retrospective data retrieved and evaluated during approximately 18.7 months; Adverse events: Not applicable as adverse events were not planned to be assessed during the study
Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (AE) (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could be met. Hence, adverse events were not planned to be evaluated (thus at risk appears "0").
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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 diagnosed with mCRPC who initiated abiraterone, in real-world setting under routine clinical practice were included. Data from these participants were observed retrospectively. No intervention was administered during this study. | 1,007 | 1,316 | 0 | 0 | 0 | 0 |
| EG001 | Enzalutamide | Participants diagnosed with mCRPC who initiated 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. | 1,036 | 1,415 | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Feb 6, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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| Black |
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| Hispanic or Latino |
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| Asian |
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| Other race |
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| Unknown |
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| OG001 | Enzalutamide Only | Participants diagnosed with mCRPC who initiated enzalutamide in real-world setting under routine clinical practice and did not receive subsequent systemic anti-neoplastic therapy were included. Data from these participants were observed retrospectively. No intervention was administered during this study. |
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| OG001 | Enzalutamide | Participants diagnosed with mCRPC who initiated 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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| Enzalutamide |
Participants diagnosed with mCRPC who initiated 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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