Status: Planned First registered on: 13/10/2020
Last updated on: 16/08/2021
1. Study identification
EU PAS Register NumberEUPAS37163
Official titleDrug utilisation study of Radium 223 under routine clinical practice in Europe
Study title acronymDIRECT
Study typeObservational study
Brief description of the studyRadium-223 is used as monotherapy or in combination with a luteinising hormone-releasing hormone (LHRH) analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases, and no known visceral metastases, or ineligible for any available systemic mCRPC therapy. A clinical trial found an imbalance of more fractures and deaths in the arm treated with radium-223 than in the control arm treated with placebo. These results triggered a change in the European Union product information in 2018. This study is to describe compliance with the label contraindication of using radium-223 in combination with abiraterone acetate or other systemic therapies for mCRPC and to describe the use of radium-223 without having received two prior lines of systemic therapy for mCRPC, but an assessment of whether this use represents on or off-label use is not possible.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Details of (Primary) lead investigator
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

Castration-resistant Prostate Cancer Registry (CAPRI), Rotterdam, Netherlands
Countries in which this study is being conducted
International study

Denmark
Germany
Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/10/201917/10/2019
Start date of data collection31/03/2022
Start date of data analysis
Date of interim report, if expected
Date of final study report30/04/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Address line 1Muellerstrasse 178
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name BAYER AG 
First name Bayer Clinical Trials 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
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