A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer

Summary

The purpose of this study is to find out what effects, good and/or bad,an increased dose of Abiraterone Acetate in combination with prednisone has on patients and their prostate cancer. This study will investigate whether an increased-dose (2,000mg daily) is safe and potentially effective when given to patients whose cancer has grown while taking the standard dose.

Timeline

Start

2013-03-13

Primary completion

2017-02-27

Completion

2017-02-27

Outcome

Missed primary endpoint

paper No PSA declines ≥ 30% nor radiographic responses were observed after 12 weeks of dose-escalated therapy. PMID 28655452 ↗

Publications

• Results Friedlander TW, Graff JN, Zejnullahu K, Anantharaman A, Zhang L, Paz R, Premasekharan G, Russell C, Huang Y, Kim W, Aggarwal RR, Lin AM, Fong L, Alumkal JJ, Beer TM, Sharifi N, Alyamani M, Dittamore R, Small EJ, Paris PL, Ryan CJ. High-Dose Abiraterone Acetate in Men With Castration Resistant Prostate Cancer. Clin Genitourin Cancer. 2017 Dec;15(6):733-741.e1. doi: 10.1016/j.clgc.2017.05.026. Epub 2017 Jun 3.

Drugs

Indications