PARABO - Pain evaluation in Radium-223 (Xofigo®) treated mCRPC patients with bone metastases – a non-interventional study in nuclear medicine centers

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42732
• EU PAS number:
  EUPAS9020
• Study ID:
  42732
• Official title and acronym:
  PARABO - Pain evaluation in Radium-223 (Xofigo®) treated mCRPC patients with bone metastases – a non-interventional study in nuclear medicine centers
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, and safety will be assessed.
• Study status:
  Finalised

Research institution and networks

Institutions

Bayer AG

Multiple centres: 30 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/09/2014

Actual: 05/09/2014

Study start date

Planned: 31/03/2015

Actual: 19/03/2015

Date of final study report

Planned: 29/01/2021

Actual: 01/06/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

XF1412_CSP_v1.0_2014-09-12_signed_reduced

Updated protocol

17550_PARABO_CSP_v6.0_2018-04-30_redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable