Trial Condition(s):
Prostatic Neoplasms, Castration-Resistant
A local retrospective observational study to evaluate the treatment patterns of mCRPC patients in Belgium treated with Radium-223 (BELFIGO)
Bayer Identifier:
20239
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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
Trial Summary
Enrollment Goal
164
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Belgium | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
1
Primary Outcome
- The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injectionsTimeframe: 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)Timeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The number of prior and post life prolonging systemic anti-cancer therapies will be describedTimeframe: 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 centerTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The occurrence of progression post first dose of Radium-223Timeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The occurrence of SSE related hospitalizationsSSE: Symptomatic Skeletal EventsTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The frequency of SSE related hospitalizationsTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The number of discontinuation of Radium-223Timeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The frequency of blood transfusionsTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The overall survival in routine clinical practiceTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPCTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The timing of progression post first dose of Radium-223Timeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The time between last Radium-223 injection and next line of systemic anti-cancer therapyTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
- The number of patients receiving next line of systemic anti-cancer therapyTimeframe: Retrospectively analysis from 22 December 2013 to 01 June 2018
Additional Information
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