B98: PRospective observational assessment of the effectiveness of Enzalutamide treatment in patients with Metastatic castration-resIstant proState cancEr in a real-world clinical practice setting: the ongoing PREMISE study

Heather Payne1,Michael Borre2,Richard Davidson3,Robert Snijder4,Maria De Santis5

1University College London Hospitals, Department of Oncology, London, UK,2Aarhus University Hospital, Department of Urology, Aarhus, Denmark,3Astellas Pharma EMEA, Chertsey, UK,4Astellas Pharma Global Development, Leiden, The Netherlands,5University of Warwick, Cancer Research Unit, Coventry, UK

Presenting date: Tuesday 3 November

Background

Enzalutamide is an androgen receptor inhibitor, approved in Europe, shown to improve survival in men with metastatic castration-resistant prostate cancer (mCRPC) before and after chemotherapy. While phase 3 enzalutamide studies provide efficacy/safety data obtained under controlled conditions, limited real-world data are available. Here, we describe the ongoing PREMISE study, which will capture data on effectiveness, health-related quality of life (HRQoL), safety and characteristics of patients with mCRPC prescribed with enzalutamide in a real-world clinical setting.

Method

PREMISE is a long-term observational study in men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice and who provided informed consent to participate. A total of 1930 patients with mCRPC are planned to be enrolled from 200 sites across Europe and South Africa. Data will be collected at baseline, all routine clinical visits (approximately every 3 months) and at study completion or disease progression for the duration of patients' treatment, and then for a minimum 7-month follow-up after discontinuation.

The primary outcome is time to treatment failure, defined as the time from treatment initiation to discontinuation for any reason. Secondary outcomes include effectiveness (time to prostate-specific antigen [PSA] progression, PSA response and time to disease progression); reasons for use and treatment duration; pain and analgesic use; HRQoL; health resource use and safety. Data will be sourced from Serious Adverse Event/Adverse Drug Reaction Worksheets, hospital records and patient-completed questionnaires.

Results

Data collection began in the second quarter of 2015 and is expected to continue until 2018. As of July 2015, 19 sites in the United Kingdom (74 total in Europe) were confirmed as suitable for study inclusion.

Conclusion

PREMISE data will contribute to the existing enzalutamide evidence base and provide valuable information on the effectiveness and safety of enzalutamide in patients with mCRPC in a real-world clinical setting.