Abiraterone acetate plus prednisone/prednisolone in hormone-sensitive and castration-resistant metastatic prostate cancer

ABSTRACT Introduction: New-generation hormonal therapies such as abiraterone acetate (AA) in combination with prednisone or prednisolone (AAP) have improved the overall survival (OS) in patients with chemotherapy-pretreated and naïve metastatic castration-resistant prostate cancer (mCRPC). More recently, AAP has demonstrated efficacy in newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) and has received expanded approval for this indication. Areas covered: This review is intended to provide a thorough overview of AA as the first-in-class and only currently approved steroid 17α-hydroxylase/C17,20-lyase (CYP17) inhibitor for prostate cancer. To the best of our knowledge, this is the most comprehensive review of AAP that covers all three indications: mCRPC in the pre- and post-chemotherapy setting, and mHSPC. We describe, among other things, the mechanism of action of AA and review data on its efficacy and safety from phase 1, 2 and the pivotal phase 3 clinical trials that support its use in the mentioned approved indications. Expert opinion: AAP has been established over the past 10 years and was added to the WHO list of essential medicines in 2019 through an evidence-based selection process in which quality, safety, efficacy, and cost-effectiveness are key criteria, highlighting its role in the current therapeutic landscape of prostate cancer management.