Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer.

ABSTRACT:

Background

In the SPARTAN study, compared with placebo, apalutamide added to ongoing androgen deprivation therapy significantly prolonged metastasis-free survival (MFS) and time to symptomatic progression in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). Overall survival (OS) results at the first interim analysis (IA1) were immature, with 104 of 427 (24%) events required for planned final OS analysis. Here, we report the results of a second pre-specified interim analysis (IA2).

Methods

One thousand two hundred and seven patients with nmCRPC were randomized 2 : 1 to apalutamide (240 mg daily) or placebo. The primary end point of the study was MFS. Subsequent therapy for metastatic CRPC was permitted. When the primary end point was met, t

SUBMITTER: Small EJ 

PROVIDER: S-EPMC6927320 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature