Darolutamide Observational Study in non-metastatic castration-resistant prostate cancer patients (DAROL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49948
• EU PAS number:
  EUPAS31734
• Study ID:
  49948
• Official title and acronym:
  Darolutamide Observational Study in non-metastatic castration-resistant prostate cancer patients (DAROL)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Brazil

  Canada

  China

  Colombia

  Denmark

  Finland

  France

  Greece

  India

  Ireland

  Italy

  Japan

  Luxembourg

  Mexico

  Netherlands

  Norway

  Russian Federation

  Slovakia

  Spain

  Sweden

  Türkiye

  United Kingdom

  United States
• Study description:
  The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Actual: 23/07/2019

Study start date

Planned: 30/01/2020

Actual: 30/01/2020

Date of final study report

Planned: 01/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

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