AUA 2018 Prostate Cancer
AUA 2018: Patient Reported Outcomes in SPARTAN, a Phase 3, Double-Blind, Randomized Study of Apalutamide plus ADT vs placebo plus ADT in Men with nmCRPC
A total of 1207 pts (median age, both arms: 74 y) with nmCRPC and PSA doubling time of 10 mo were randomized 2:1 to APA (240 mg QD) or PBO. ADT was continued. HRQoL and symptoms were assessed using PRO questionnaires, including the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Euro QoL Group EQ-5D3L. PROs were completed at baseline, Day 1 of Cycles (C) 2-7, C9, C11, C13, and then every 4 mo for the duration of treatment and 1 y after treatment discontinuation. Analyses were conducted on FACT-P total score and all subscales, including FACT-G, a more general evaluation of HRQoL.