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

NCT03563014 — Completed, 164 participants, Bayer

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RegistryNCT03563014, acronym BELFIGO
StatusCompleted
Study typeObservational
Enrollment164 (Actual)
SponsorBayer (Industry)
ConditionsProstatic Neoplasms, Castration-Resistant
InterventionsRadium-223 (Xofigo, Bay88-8223) (Drug)
Datesstart 2018-07-31, primary completion 2019-01-31, completion 2019-01-31, first posted 2018-06-20, last updated 2020-05-20
Locations1 site in Belgium

Related Papers Related Patents Related Grants Related Experts
All trials for Prostatic Neoplasms, Castration-Resistant All trials of Radium-223 (Xofigo, Bay88-8223)

-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.

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+Arms and interventions

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

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

Sex: Male

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

+Locations (1)

FacilityCityCountryStatus
Many LocationsMultiple LocationsBelgium