1766MO Health-related quality of life (HRQoL) in nonmetastatic hormone-sensitive prostate cancer (nmHSPC) patients (pts) with high-risk biochemical recurrence (BCR) from the EMBARK study

摘要: BackgroundEnzalutamide (ENZ)+ leuprolide acetate (L) and ENZ alone delayed metastasis-free survival (MFS) vs placebo (P)+ L in high-risk BCR nmHSPC in the phase 3 EMBARK (NCT02319837) trial. Pt-reported outcomes (PROs) provide a pt perspective on disease/treatment (Tx) experience not captured by clinical assessment.MethodsnmHSPC pts with high-risk BCR (prostate-specific antigen [PSA] doubling time≤ 9 months, screening PSA≥ 2 ng/mL above nadir post radiotherapy or≥ 1 ng/mL post radical prostatectomy) were randomized (1: 1: 1) to ENZ+ L, ENZ alone, and P+ L. PROs were assessed at baseline (BL) and every 12 weeks until development of metastasis or death. The main objectives were to assess Tx effects in time to first and confirmed (at next visit) clinically meaningful deterioration (TTFD/TTFCD) as measured with the Brief Pain Inventory Short Form (BPI-SF) worst pain and Functional …