Assessment of the Safety of Glucocorticoid Regimens in Combination With Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer: A Randomized, Open-label Phase 2 Study.

ABSTRACT:

Importance

Abiraterone acetate is combined with prednisone, 5 mg, twice daily for metastatic castration-resistant prostate cancer (mCRPC) and with prednisone, 5 mg, once daily for newly diagnosed, high-risk, metastatic castration-sensitive prostate cancer. Understanding the physiological effects of these and other regimens is important.

Objective

To evaluate the safety of abiraterone acetate with 4 glucocorticoid regimens.

Design, setting, and participants

Open-label, randomized clinical trial (1:1:1:1) of 164 men with mCRPC from 22 hospitals in 5 countries who were randomly assigned to 1 of 4 intervention groups between June 2013 and October 2014. Analyses were conducted from August 2017 to June 2018.

Interventions

Abiraterone acetate, 1000 mg, once daily with

SUBMITTER: Attard G 

PROVIDER: S-EPMC6604092 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature