check_circleStudy Completed
Prostatic Neoplasms, Castration-Resistant
Bayer Identifier:
20239
ClinicalTrials.gov Identifier:
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
MaleAge
N/A N/ATrial summary
Enrollment Goal
164Trial Dates
July 2018 - January 2019Phase
Phase 4Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Belgium |
Primary Outcome
- The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injectionsdate_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 describeddate_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-223By stratification according to the number of months after the very first index date per centerdate_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The occurrence of progression post first dose of Radium-223date_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The occurrence of SSE related hospitalizationsSSE: Symptomatic Skeletal Eventsdate_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The frequency of SSE related hospitalizationsdate_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The number of discontinuation of Radium-223date_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The frequency of blood transfusionsdate_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The overall survival in routine clinical practicedate_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 mCRPCdate_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The timing of progression post first dose of Radium-223date_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 therapydate_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
- The number of patients receiving next line of systemic anti-cancer therapydate_rangeTime Frame:Retrospectively analysis from 22 December 2013 to 01 June 2018
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A