Study identification

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 (Study was withdrawn prior to enrollment)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
First published:
01/02/2024
Institution
Multiple centres: 70 centres are involved in the study

Contact details

Beauval Jean-baptiste

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
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