Prostatic Neoplasms, Castration-Resistant
Conditions
Keywords
Radium-223, Metastatic castration-resistant prostate cancer, CRPC, Phase IV
Brief 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.
Interventions
Follow the physician's prescription in routine clinical practice.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 | — |
| The frequency of blood transfusions | Retrospectively analysis from 22 December 2013 to 01 June 2018 | — |
Countries
Belgium
Outcome results
None listed