check_circleStudy Completed

Prostatic Neoplasms, Castration-Resistant

Bayer Identifier:

20239

ClinicalTrials.gov Identifier:

NCT03563014

EudraCT Number:

Not Available

EU CT Number:

Not Available
A local retrospective observational study to evaluate the treatment patterns of mCRPC patients in Belgium treated with Radium-223

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

N/A N/A
  • - 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)
  • - 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

Trial summary

Enrollment Goal
164
Trial Dates
July 2018 - January 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Belgium

Primary Outcome

  • The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The occurrence of progression post first dose of Radium-223
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The occurrence of SSE related hospitalizations
    SSE: Symptomatic Skeletal Events
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The frequency of SSE related hospitalizations
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The number of discontinuation of Radium-223
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The frequency of blood transfusions
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The overall survival in routine clinical practice
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The timing of progression post first dose of Radium-223
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018
  • The number of patients receiving next line of systemic anti-cancer therapy
    date_rangeTime Frame:
    Retrospectively analysis from 22 December 2013 to 01 June 2018

Trial design

A local retrospective observational study to evaluate the treatment patterns of mCRPC patients in Belgium treated with Radium-223
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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