Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist, in the High-risk Nonmetastatic Castration-resistant Prostate Cancer Cohort.

ABSTRACT:

Background

Apalutamide is a potent androgen receptor (AR) antagonist that targets the AR ligand-binding domain and prevents AR nuclear translocation, DNA binding, and transcription of AR gene targets.

Objective

To evaluate the activity and safety of apalutamide in patients with high-risk nonmetastatic castration-resistant prostate cancer (nmCRPC).

Design, setting, and participants

We conducted a multicenter phase 2 study of nmCRPC patients with a high risk for progression (prostate-specific antigen [PSA] ≥8 ng/ml or PSA doubling time [PSA DT] ≤10 mo).

Intervention

Patients received 240mg/d apalutamide while continuing on androgen-deprivation therapy.

Outcome measurements and statistical analysis

Primary end point was 12-wk PSA response (Prostate Cancer W

SUBMITTER: Smith MR 

PROVIDER: S-EPMC5568792 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature