Duration of treatment with abiraterone acetate in mCRPC
Research type
Research Study
Full title
A retrospective, international, multicentre study to describe the duration of routine treatment with abiraterone acetate in metastatic castration-resistant prostate cancer (mCRPC) patients without prior chemotherapy.
IRAS ID
199168
Contact name
Lindsay Dearden
Contact email
Sponsor organisation
Janssen-Cilag International NV
Duration of Study in the UK
0 years, 9 months, 14 days
Research summary
Abiraterone acetate is approved by the European Medicines Agency (EMA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after the failure of androgen deprivation therapy (ADT) and in whom chemotherapy is not yet clinically indicated. There is a growing need from providers as well as healthcare authorities for real-world data that provide greater understanding of the relative effectiveness and value of a new treatment in routine clinical practice.
The primary objective of this study is to describe the duration of treatment with abiraterone acetate in mCRPC patients who have progressed on ADT and have not yet been treated with chemotherapy. This study will also provide an understanding of how patients with mCRPC treated with abiraterone acetate in this setting are generally managed in routine clinical practice and their associated outcomes.
Retrospective data available from the medical records of patients who started treatment with abiraterone acetate between 01 January 2013 (or the date that abiraterone acetate first became available at the site) and 31 December 2014, will be collected.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/0232
Date of REC Opinion
2 Feb 2016
REC opinion
Further Information Favourable Opinion