Study identification

PURI

https://redirect.ema.europa.eu/resource/46942

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 institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
Castration-resistant Prostate Cancer Registry (CAPRI) Rotterdam, Netherlands

Contact details

Bayer Clinical Trials BAYER AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Study protocol
Initial protocol

20702_Study Protocol_Redacted_V2.0_2019-07-15

English (1.54 MB - PDF)View document
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)