European urology oncology · 2026
Associations Between Quality of Life and Disease Progression in Metastatic Hormone-sensitive Prostate Cancer: Insights from ARASENS and ARANOTE Trials.
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Morgans Alicia K, Ekberg Sara, Boegemann Martin, Paracha Noman, Gallagher Elaine, Gasparini Alessandro, Crowther Michael J, Shore Neal, Wallis Christopher J D
Аннотация
BACKGROUND: Maintaining quality of life (QoL) is an important treatment goal in metastatic hormone-sensitive prostate cancer (mHSPC). Evidence remains limited regarding longitudinal QoL changes, prognostic value, and contribution to treatment benefit.
OBJECTIVE: We examined longitudinal QoL patterns, their association with castration resistance or death (CROD) and radiological progression or death (rPFS), and the contribution of QoL to the effect of darolutamide.
DESIGN, SETTING AND PARTICIPANTS: We analyzed data from two randomized phase III trials: ARASENS (ADT + docetaxel ± darolutamide) and ARANOTE (ADT ± darolutamide).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: QoL was assessed using NCCN-FACT FPSI-17 (ARASENS) and FACT-P (ARANOTE). Joint models linked QoL with CROD (ARASENS) and rPFS (ARANOTE), accounting for informative missingness.
RESULTS AND LIMITATIONS: Patients receiving darolutamide maintained higher QoL versus those receiving placebo. QoL decline meeting the minimally important difference (MID) was associated with higher CROD rate and shorter rPFS (HR 2.58 [95% CI: 1.76-3.78] and HR 1.32 [1.00-1.75], respectively). Higher baseline QoL was associated with improved rPFS for FACT-P (HR 0.84 [0.76-0.92] per MID) but no clear association was observed for NCCN-FACT FPSI-17 (HR 0.95 [0.89-1.02]). Joint modeling indicated that the total effect of darolutamide was largely driven by a direct component, with a smaller indirect component related to preserved QoL. Interpretation is limited by differences in disease progression definitions and QoL instruments between trials.
CONCLUSIONS: Darolutamide improved CROD/rPFS while maintaining QoL better than placebo. QoL decline preceded progression, supporting routine QoL monitoring as an early marker of disease progression.
OBJECTIVE: We examined longitudinal QoL patterns, their association with castration resistance or death (CROD) and radiological progression or death (rPFS), and the contribution of QoL to the effect of darolutamide.
DESIGN, SETTING AND PARTICIPANTS: We analyzed data from two randomized phase III trials: ARASENS (ADT + docetaxel ± darolutamide) and ARANOTE (ADT ± darolutamide).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: QoL was assessed using NCCN-FACT FPSI-17 (ARASENS) and FACT-P (ARANOTE). Joint models linked QoL with CROD (ARASENS) and rPFS (ARANOTE), accounting for informative missingness.
RESULTS AND LIMITATIONS: Patients receiving darolutamide maintained higher QoL versus those receiving placebo. QoL decline meeting the minimally important difference (MID) was associated with higher CROD rate and shorter rPFS (HR 2.58 [95% CI: 1.76-3.78] and HR 1.32 [1.00-1.75], respectively). Higher baseline QoL was associated with improved rPFS for FACT-P (HR 0.84 [0.76-0.92] per MID) but no clear association was observed for NCCN-FACT FPSI-17 (HR 0.95 [0.89-1.02]). Joint modeling indicated that the total effect of darolutamide was largely driven by a direct component, with a smaller indirect component related to preserved QoL. Interpretation is limited by differences in disease progression definitions and QoL instruments between trials.
CONCLUSIONS: Darolutamide improved CROD/rPFS while maintaining QoL better than placebo. QoL decline preceded progression, supporting routine QoL monitoring as an early marker of disease progression.