Study to Gather Information About the Use of Healthcare Services and the Way the Disease is Cared for in Canadian Patients With Prostate Gland Cancer Which Spread Throughout the Body

Study Overview
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Brief Summary
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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.

Official Title
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Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Use of at least 2 lines of life-prolonging mCRPC therapy The 2nd line of life-prolonging therapy was initiated between 01-Jan-2012 to 31-Dec-2017 Exclusion Criteria: - No formal exclusion criteria will be applied in order to capture real world use of Ra-223
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Ra-223 received<br>Patients did not receive Ra-223 | |
| Early Ra-223 (2nd line)<br>Patients received Ra-223 in 2nd line | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Follow clinical administration<br>|
| Late Ra-223 (3rd or later lines)<br>Patients received Ra-223 in 3rd or later lines | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Follow clinical administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: A change in life-prolonging treatment Death from any cause | Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 | 
| Time to External Beam Radiation Therapy (EBRT) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic castrate resistant prostate cancer mCRPC