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Completed

NCT Number: NCT03563014

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

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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Key information

Conditions

Prostatic Neoplasms, Castration-Resistant Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations

Multiple Locations, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 (Xofigo, Bay88-8223)

Drug

Follow the physician's prescription in routine clinical practice.

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

    Time frame: 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

  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

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

    SSE: Symptomatic Skeletal Events

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: BELFIGO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2018
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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