Drug utilisation study of Radium 223 under routine clinical practice in Europe (DIRECT)

Study identification

• EU PAS number:
  EUPAS37163
• Study ID:
  46942
• Official title and acronym:
  Drug utilisation study of Radium 223 under routine clinical practice in Europe (DIRECT)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Netherlands
• Study description:
  Radium-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.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Aarhus University & Aarhus University Hospital CLINICAL EPIDEMIOLOGY AND DATA SCIENCE, DEPARTMENT OF CLINICAL MEDICINE

Denmark

Castration-resistant Prostate Cancer Registry (CAPRI) Rotterdam, Netherlands

Study timelines

Date when funding contract was signed

Planned:17/10/2019

Actual:17/10/2019

Study start date

Planned:31/03/2022

Actual:15/05/2021

Date of final study report

Planned:30/04/2024

Actual:01/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)