Observational Study of Patients Treated with New Available Formulation of Enantone in Prostate Cancer (ONE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34463
• EU PAS number:
  EUPAS27547
• Study ID:
  34463
• Official title and acronym:
  Observational Study of Patients Treated with New Available Formulation of Enantone in Prostate Cancer (ONE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This is an observational, non-interventional, national, multicenter, prospective, longitudinal study of patients with prostate cancer. This study will review the medical records of patients to provide knowledge with the new formulation of Enantone in real-life setting and to assess satisfaction of patients and healthcare staff about Enantone. The patients with prostate cancer who are initiating Enantone 3.75 milligram (mg), 11.25 mg, or 30 mg in pre-filled syringe under standard regular care will be eligible for this study. The study will enroll approximately 200 patients. The study will be conducted at 70 investigative sites in France. The overall time to participate in this study is 18 months. Patients will be followed up for up to 6 months after initiation of treatment. (Study was withdrawn prior to enrollment)
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Multiple centres: 70 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 25/07/2018

Study start date

Planned: 15/01/2020

Actual: 01/04/2020

Data analysis start date

Planned: 15/04/2020

Date of final study report

Planned: 15/06/2020

Actual: 01/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

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