. Author manuscript; available in PMC: 2022 Jun 21.

Published in final edited form as: Clin Genitourin Cancer. 2020 May 11;18(6):425–428. doi: 10.1016/j.clgc.2020.05.003

Table 1.

Recent Randomized Trials Investigating Androgen Receptor Inhibitors in Metastatic Hormone-sensitive Prostate Cancer

Author	Study	Phase	No. Patients	Experimental Arm	Control Arm	Primary Endpoint	Subset Analysis
Armstrong AJ et al⁷	ARCHES	III	1150	Enzalutamide 160 mg/ day + ADT (n = 574)	Placebo + ADT (n = 576)	rPFS: NR vs. 19.4 mos (HR, 0.39; 95% CI, 0.30-0.50; P < .0001)	In docetaxel pretreated patients (18% of study population), HR favored enzalutamide arm (HR, 0.53; 95% CI, 0.31-0.92) for rPFS
Chi KN et al⁸	TITAN	III	1052	Apalutamide 240 mg/day + ADT (n = 525)	Placebo + ADT (n = 527)	rPFS at 24 months: 68.2% vs. 47.5% (HR, 0.48; 95% CI, 0.51-0.89)	In docetaxel pretreated patients (10.7% of study population), HR trended towards improvement with apalutamide (HR, 0.47; 95% CI, 0.22-1.01) for 24-month rPFS
Davis ID et al⁹	ENZAMET	III	1125	Enzalutamide 160 mg/day + ADT	ADT (continued nonsteroidal antiandrogen)	3-year OS: 80% vs. 72% (HR, 0.67; 95% CI, 0.52-0.86)	In early docetaxel group (45% vs. 44%), HR favored enzalutamide arm (HR, 0.48; 95% CI, 0.36-0.62) for endpoint of PFS

Abbreviations: ADT = Androgen deprivation therapy; CI = confidence interval; HR = hazard ratio; NR = not reached; OS = overall survival; PFS = progression-free survival; rPFS = radiographic progression-free survival.