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CompletedNCT03563014BELFIGOUpdated May 20, 2020

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

An observational study in Prostatic Neoplasms, Castration-Resistant, sponsored by Bayer. Completed at 1 site in Belgium. Open to male participants. Per ClinicalTrials.gov, last updated 2020-05-20.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
164
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostatic Neoplasms, Castration-Resistant

Keywords

  • Radium-223
  • Metastatic castration-resistant prostate cancer
  • CRPC
  • Phase IV
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 164 is below the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
164 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • DrugRadium-223 (Xofigo, Bay88-8223)

    Follow the physician's prescription in routine clinical practice.

06

What researchers measure

Primary outcomes

  1. The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

Secondary outcomes

  1. 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)

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  2. The number of prior and post life prolonging systemic anti-cancer therapies will be described

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  3. 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

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  4. The occurrence of progression post first dose of Radium-223

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  5. The occurrence of SSE related hospitalizations

    SSE: Symptomatic Skeletal Events

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  6. The frequency of SSE related hospitalizations

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  7. The number of discontinuation of Radium-223

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  8. The frequency of blood transfusions

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  9. The overall survival in routine clinical practice

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  10. The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPC

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  11. The timing of progression post first dose of Radium-223

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  12. The time between last Radium-223 injection and next line of systemic anti-cancer therapy

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

  13. The number of patients receiving next line of systemic anti-cancer therapy

    Time frame: Retrospectively analysis from 22 December 2013 to 01 June 2018

07

Study locations

1 site
  • Many Locations
    Multiple Locations, Belgium
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03563014
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Jun 20, 2018
Start date
Jul 31, 2018
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019
Last update
May 20, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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