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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03563014

Collaborator

(none)

164

Enrollment

Location

Actual Duration (Months)

27.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms, Castration-Resistant	Drug: Radium-223 (Xofigo, Bay88-8223)

Study Design

Study Type:

Observational

Actual Enrollment :

164 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 31, 2018

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

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

Drug: Radium-223 (Xofigo, Bay88-8223)

Follow the physician's prescription in routine clinical practice.

Outcome Measures

Primary Outcome Measures

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

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 [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 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 [Retrospectively analysis from 22 December 2013 to 01 June 2018]
SSE: Symptomatic Skeletal Events
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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