A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223

Study Overview
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Brief Summary
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The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion.

Official Title
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A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223

Conditions
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Prostatic Neoplasms, Castration-Resistant

Intervention / Treatment
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* Drug: Radium-223 (Xofigo, Bay88-8223)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases All consecutive patients who started Radium-223 treatment between 22 December 2014 and 01 June 2017 Availability of medical records during the observation period (22DEC2013 - 01JUN2018) Exclusion Criteria: Patients treated with Radium-223 for any reason before 22 December 2014 (for example an interventional trial) Patients participated in an investigational program with interventions outside of routine clinical practice during the radium-223 treatment period Patients received other radiopharmaceuticals for the systemic concomitant use for treatment of prostate cancer or for other use during the Radium-223 treatment period
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 |
| --- | --- |
| Radium-223 (Xofigo, Bay88-8223)<br>Belgium patients with a diagnosis of mCRPC (no known visceral metastases) and who were treated with Radium-223 for this indication | Drug: Radium-223 (Xofigo, Bay88-8223)<br>* Follow the physician's prescription in routine clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections by Radium-223 line of treatment (1st, 2nd and further line) |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The number of prior and post life prolonging systemic anti-cancer therapies will be described |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The characteristics of patients according to the experience of the study centers with Radium-223 | By stratification according to the number of months after the very first index date per center | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The occurrence of progression post first dose of Radium-223 |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The occurrence of SSE related hospitalizations | SSE: Symptomatic Skeletal Events | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The frequency of SSE related hospitalizations |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The number of discontinuation of Radium-223 |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The frequency of blood transfusions |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The overall survival in routine clinical practice |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPC |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The timing of progression post first dose of Radium-223 |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The time between last Radium-223 injection and next line of systemic anti-cancer therapy |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 
| The number of patients receiving next line of systemic anti-cancer therapy |  | Retrospectively analysis from 22 December 2013 to 01 June 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radium-223, Metastatic castration-resistant prostate cancer, CRPC, Phase IV