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

Prostatic Neoplasms, Castration-Resistant Clinical Trial

— BELFIGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563014
• Other study ID #: 20239
• Status: Completed
• Start date: July 31, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• Radium-223 (Xofigo, Bay88-8223)
Follow the physician's prescription in routine clinical practice.

Locations

Country	Name	City	State
Belgium	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	The occurrence of progression post first dose of Radium-223		Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary	The occurrence of SSE related hospitalizations	SSE: Symptomatic Skeletal Events	Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary	The frequency of SSE related hospitalizations		Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary	The number of discontinuation of Radium-223		Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary	The frequency of blood transfusions		Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary	The overall survival in routine clinical practice		Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary	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
Secondary	The timing of progression post first dose of Radium-223		Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary	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
Secondary	The number of patients receiving next line of systemic anti-cancer therapy		Retrospectively analysis from 22 December 2013 to 01 June 2018

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