Study identification

EU PAS number

EUPAS7187

Study ID

33628

Official title and acronym

Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation (REASSURE)

DARWIN EU® study

No

Study countries

Argentina
Austria
Belgium
Canada
Colombia
Czechia
Denmark
France
Germany
Greece
Israel
Italy
Luxembourg
Mexico
Netherlands
Portugal
Spain
Sweden
United Kingdom
United States

Study description

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Study status

Ongoing
Research institutions and networks

Institutions

Bayer AG
First published:
01/02/2024
Institution

Contact details

Bayer Clinical Trials Contact Bayer AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
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)