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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms, Castration-Resistant
• Intervention / Treatment: Drug: Radium-223 (Xofigo, Bay88-8223)

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Belgian patients who were treated with Radium-223 for (metastatic) Castration Resistant Prostate Cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Phase IV; Radium-223; CRPC; Metastatic castration-resistant prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 20239

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No