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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33628
• 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

Study timelines

Date when funding contract was signed

Actual: 05/05/2014

Study start date

Planned: 31/08/2014

Actual: 20/08/2014

Date of final study report

Planned: 30/06/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

16913_ REASSURE_Study Protocol

Updated protocol

16913_Study Protocol_V5.0_2018-08-20_Redacted

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)

Other study registration identification numbers and links

CT.gov number: NCT02141438