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

Completed

• Conditions: Prostatic Neoplasms, Castration-Resistant
• Interventions: Drug: Radium-223 (Xofigo, Bay88-8223)

• Registration Number: NCT03563014
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Study Start: 2018-07-31
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 164

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radium-223 (Xofigo, Bay88-8223)	Radium-223 (Xofigo, Bay88-8223)	Belgium patients with a diagnosis of mCRPC (no known visceral metastases) and who were treated with Radium-223 for this indication

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 occurrence of SSE related hospitalizations	Retrospectively analysis from 22 December 2013 to 01 June 2018	SSE: Symptomatic Skeletal Events
The overall survival in routine clinical practice	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	Retrospectively analysis from 22 December 2013 to 01 June 2018	By stratification according to the number of months after the very first index date per center
The frequency of blood transfusions	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 frequency of SSE related hospitalizations	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 number of patients receiving next line of systemic anti-cancer therapy	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 number of discontinuation of Radium-223	Retrospectively analysis from 22 December 2013 to 01 June 2018
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 time between last Radium-223 injection and next line of systemic anti-cancer therapy	Retrospectively analysis from 22 December 2013 to 01 June 2018

Trial Locations

Locations (1)

Many Locations; 🇧🇪 Multiple Locations, Belgium