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Study to gather information about the optimal placement of Ra-223 in the order of different treatments in terms of the effect on patients and in terms of the use of healthcare services for the treatment of Canadian patients with prostate gland cancer which spread to other parts of the body. In order to collect this information real world data from prostate gland cancer patients from four Canadian administrative databases will be analyzed.
Data collected from patients treated with their 2nd line of life-prolonging therapy for Non-Metastatic Castration Resistant Prostate Cancer (mCRPC) initiated from 01 Jan 2012 to 31 Dec 2017. For patients included in the study, all available data from the beginning for their record until death, lost to follow-up or database cut-off will be included. The index date is the date of initiation of the 2nd line life-prolonging therapy for mCRPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Ra-223 received | Patients did not receive Ra-223 | ||
| Early Ra-223 (2nd line) | Patients received Ra-223 in 2nd line |
| |
| Late Ra-223 (3rd or later lines) | Patients received Ra-223 in 3rd or later lines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Follow clinical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The length of time from the date of initiation of 2nd line life-prolonging therapy to death due to any cause | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | The length of time from the start of 2nd line life-prolonging therapy to the earliest occurrence of one of the following:
| Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Time to External Beam Radiation Therapy (EBRT) |
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Inclusion Criteria:
Exclusion Criteria:
- No formal exclusion criteria will be applied in order to capture real world use of Ra-223
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Men with mCRPC and at least 2 lines of life-prolonging therapy initiated between 01 Jan 2012 to 31 Dec 2017. No formal exclusion criteria will be applied in order to capture real world use of Ra-223.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Multiple Locations | Canada |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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From the start of the 1st life-prolonging therapy (index date) until the first use of EBRT |
| Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Total incidence of EBRT | Total number of EBRT treatments received over the course of the patient's journey starting from the initiation of 2nd line life-prolonging therapy (index date) until death. | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Time to first hospitalization | Measured from the start of the 2nd line life-prolonging therapy (index date) until the first overnight hospital stay. | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Number of overnight hospital stays | Measured from the initiation of 2nd line life-prolonging therapy (index date) until death | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Average length of hospital stays (number of days) | Measured from the initiation of 2nd line life -prolonging therapy (index date) until death | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Time to first Emergency Room (ER) visit | Measured from the start of 2nd line life-prolonging therapy (index date) until the first ER visit. | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| Number of visits to the ER | Measured from the initiation of 2nd line life-prolonging therapy (index date) until death | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 |
| 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 |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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