RENAISSANCE - A multi-centre, non-interventional study of RElugolix as aNdrogen-deprivAtion therapy In patientS with advanced hormone-Sensitive prostate cANCEr

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000077
• EU PAS number:
  EUPAS1000000077
• Study ID:
  1000000077
• Official title and acronym:
  RENAISSANCE - A multi-centre, non-interventional study of RElugolix as aNdrogen-deprivAtion therapy In patientS with advanced hormone-Sensitive prostate cANCEr
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Romania

  Spain

  United Kingdom
• Study status:
  Planned

Research institutions and networks

Institutions

Accord Healthcare Limited

Study timelines

Date when funding contract was signed

Planned: 01/01/2024

Study start date

Planned: 01/05/2024

Date of final study report

Planned: 01/08/2026

Sources of funding

Pharmaceutical company and other private sector 

Study protocol

Initial protocol

Relugolix NIS protocol 19022024 VF.pdf

Regulatory

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