PRECISE/Rates of bone fractures and survival in metastatic castration-resistant PRostate cancer (mCRPC) PatiEnts treated with Radium-223 in routine Clinical practIce in SwedEn

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42249
• EU PAS number:
  EUPAS33448
• Study ID:
  42249
• Official title and acronym:
  PRECISE/Rates of bone fractures and survival in metastatic castration-resistant PRostate cancer (mCRPC) PatiEnts treated with Radium-223 in routine Clinical practIce in SwedEn
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Networks

The Prostate Cancer data Base Sweden (PCBaSe)

Study timelines

Date when funding contract was signed

Planned: 05/12/2018

Actual: 05/12/2018

Study start date

Planned: 15/02/2020

Actual: 15/02/2020

Date of final study report

Planned: 30/06/2021

Actual: 14/06/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

20437_Study Protocol_V2.1_2019-09-06_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/PSP/S/0076