PREMISE: European Observational Study of Enzalutamide in mCRPC (v2.0)
Research type
Research Study
Full title
PREMISE: A European PRospective Observational Study Assessing the Effectiveness and Outcomes Associated with Enzalutamide Treatment in Patients with Metastatic Castration ResIstant ProState CancEr (mCRPC). Version 2.0
IRAS ID
180522
Contact name
Angus Robinson
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The study, which is Sponsored by Astellas, is designed to observe the long term effectiveness of enzalutamide when used in routine clinical care to treat patients with a form of prostate cancer called metastatic castration resistant prostate cancer (mCRPC), where the cancer has spread to parts of the body other than the prostate. Patients will be approached for study inclusion only after the patient's doctor has made the independent clinical decision to treat the patient with enzalutamide. Information will be collected and recorded by the patient's doctor during routine clinical visits. The frequency of the routine clinic visits will be according to the normal standard of care at the site. Patient progress will be followed for up to 18 months to collect information that will help doctors to decide which drugs,combinations of drugs or other treatments are most effective in the long term treatment of mCRPC. During routine clinic visits patients will be asked to complete paper questionnaires about their symptoms, treatment, use of health care resources, pain and quality of life. They will also be asked about any side effects experienced. The study will enrol approximately 1930 patients from 16 countries. Patient information collected during the study may be used in reports of the study or for scientific presentations, however all personal information will remain confidential.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0177
Date of REC Opinion
6 Jul 2015
REC opinion
Further Information Favourable Opinion