Clinical trial NCT03563014: A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
Official title: A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms, Castration-Resistant
Keywords: Radium-223
Metastatic castration-resistant prostate cancer
CRPC
Phase IV
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 164
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Belgian patients who were treated with Radium-223 for (metastatic) Castration Resistant Prostate Cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Secondary outcomes:
measure: 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)
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The number of prior and post life prolonging systemic anti-cancer therapies will be described
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The characteristics of patients according to the experience of the study centers with Radium-223
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The occurrence of progression post first dose of Radium-223
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The occurrence of SSE related hospitalizations
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The frequency of SSE related hospitalizations
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The number of discontinuation of Radium-223
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The frequency of blood transfusions
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The overall survival in routine clinical practice
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPC
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The timing of progression post first dose of Radium-223
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The time between last Radium-223 injection and next line of systemic anti-cancer therapy
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
measure: The number of patients receiving next line of systemic anti-cancer therapy
timeFrame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Many Locations
Study officials:
References: