ARASENS
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled Phase III study of ODM-201 versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone-sensitive prostate cancer
IRAS ID
211988
Contact name
Ursula McGovern
Contact email
Sponsor organisation
Bayer AG
Eudract number
2015-002590-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, 0 days
Research summary
This is a randomised, multicentre Phase III study in which 1300 patients with metastatic hormone sensitive prostate cancer (mHSPC) will be recruited.
The purpose of this study is to find out if ODM-201 is effective at keeping cancer under control when given in addition to standard treatment which includes androgen deprivation therapy (ADT) and docetaxel chemotherapy for six cycles.
All patients participating in the study will be treated with ADT and docetaxel, in addition to ODM-201 or placebo.
Patients will visit the study site every 12 weeks approximately until up to 1 year after stopping ODM-201/placebo (with the exception of the docetaxel chemotherapy period, when visits will be according to the local clinical practice, at least once every 21 days).
During the study visits patients will have a number of assessments, including blood tests, physical examinations, assessment of pain, MRI or CT scans, and are asked to complete quality of life questionnaires.Treatment with ODM-201 or placebo will be provided until one of the following:
- patient’s disease progresses
- until unacceptable side effects
- change of treatment
- withdrawal of consent
study doctor considers that treatment with ODM-201 is no longer beneficial to the patient.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0353
Date of REC Opinion
7 Dec 2016
REC opinion
Further Information Favourable Opinion