AQUARiUS
Research type
Research Study
Full title
Prospective Multi-country Observational Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Patient-reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Patients
IRAS ID
204566
Contact name
Martin Kluska
Contact email
Sponsor organisation
Janssen Pharmaceutica NV
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
This is a prospective observational, multicentre study to document the impact of abiraterone acetate and enzalutamide treatment on Health related Quality of Life (HRQoL), fatigue, pain, cognitive function and Medical resource Use (MRU) in metastatic castration resistant prostate cancer (mCRPC) patients in routine clinical practice. The study will use patient completed questionnaires and routine clinical examinations to investigate potential associations between treatments and changes of HRQoL in the study population.
Patients will be invited to participate in the study by their treating physician at the time of initiation of mCRPC treatment with either abiraterone acetate or enzalutamide. The decision to treat patients with abiraterone acetate or enzalutamide must have been taken independently of and before enrolling the
patient into the study. Treatment decisions and clinical management of patients will be at the discretion of the treating physician, per routine clinical practice. The decision of patients to take part in the study will not influence their medical care. Patient data will be collected in the electronic case report form (eCRF),
after provision of written consent signed by the patient, per local requirements. The study duration for patients is up to 12 months.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0191
Date of REC Opinion
6 May 2016
REC opinion
Favourable Opinion