Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT06151418 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Men in this study will be taking NHT for treatment of their mCSPC. The study will explain:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel hormonal therapy cohort | Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel hormonal therapy | Drug | As provided in real-world setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
Exclusion Criteria:
Evidence of castration-resistance prior to the index date
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
Not provided
Not provided
Men with metastatic castration-sensitive prostate cancer who initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) and met eligibility criteria will be included in the study. Patients will be identified from the National Veterans Affairs Health Care Network.
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Nov 6, 2023 |
Not provided
Not provided
Not provided
Not provided
| From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Data is reported as retrieved from medical records in accordance to protocol. | Count of Participants | Participants |
|
| 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 | 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). | Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study. | Posted | Median | 95% Confidence Interval | Months | From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 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. | Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study. | Posted | Median | 95% Confidence Interval | Months | From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months |
|
|
Data for adverse events and death were not planned to be evaluated during the study; hence timeframe is not applicable
Due to non-interventional nature of the study, minimum criteria for reporting an adverse event could not be met, hence adverse events were not planned to be evaluated. Thus, explaining 0 participant at risk.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
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_Inquires@pfizer.com |
| Apr 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| C572045 | apalutamide |
| C540278 | enzalutamide |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Greater than or equal to (>=) 80 |
|
| Hispanic |
|
| Other |
|
| Unknown |
|
|