Patient-Reported Outcomes on Quality of Life and Psychological Distress After Focal High-Intensity Focused Ultrasound for Prostate Cancer: Prospective Multicenter Study.

Background: Focal high-intensity focused ultrasound (HIFU) is an emerging tissue-preserving treatment for localized prostate cancer (PCa) that aims to reduce functional impairment and psychological burden while maintaining oncological safety. Although its clinical use is increasing, prospective data on health-related quality of life (HRQoL) and psychological distress after focal hemiablation remain limited. Objective: This study aims to evaluate longitudinal HRQoL trajectories and psychological outcomes in patients eligible for active surveillance who underwent focal HIFU following shared decision-making. Methods: This prospective, multicenter, single-arm longitudinal study included men with unilateral, organ-confined PCa treated with focal HIFU hemiablation within the HEMI study (AP study protocol/reference number: 68/11, AUO). All patients had concordant multiparametric magnetic resonance imaging and biopsy findings, and underwent standardized unilateral HIFU. HRQoL was assessed at baseline and at 1, 3, 6, 9, and 12 months using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30, version 3.0). Psychological distress was measured with the Hospital Anxiety and Depression Scale. Longitudinal changes were analyzed using linear mixed-effects models with false discovery rate correction. In addition, univariate regression analyses were performed to assess associations between clinical and functional parameters, and HRQoL outcomes. Outcomes were compared with German and Norwegian normative populations, and clinical relevance was interpreted using Osoba criteria. Results: Fifty-four patients were included, of whom 51 (94.4%) completed 12-month follow-up (mean age 63.4, SD 8.3 y). Baseline HRQoL, functional status, and symptom burden were favorable. One month after hemi-HIFU, a statistically significant and clinically moderate decline in global health status was observed (mean 75 [SD 17.8] vs 63 [SD 17.9]; P=.002; Cohen d=0.58). This transient deterioration was mainly driven by increased fatigue, pain, insomnia, appetite loss, and reduced physical, role, and social functioning, with social functioning most affected. Emotional and cognitive functioning remained stable. From 3 months onward, HRQoL and all functional domains recovered to baseline or higher levels, with no clinically relevant impairments at 12 months. Symptom burden normalized across most domains after 3 months, although mild constipation remained slightly elevated. Depression scores showed a transient increase at 1 and 3 months but remained below clinical thresholds, whereas anxiety scores were stable at all time points. In univariate regression analyses, no clinical or functional parameters were identified as independent predictors of HRQoL. Overall, recovery was rapid, long-term HRQoL was preserved, and treatment-related morbidity remained low. Conclusions: Focal HIFU hemiablation preserves long-term HRQoL and psychological well-being in carefully selected patients with localized PCa. Early postoperative impairment is temporary, with recovery to baseline and convergence with normative population values from 3 months onward. Clinical and functional parameters were not significant predictors of HRQoL. These findings support focal HIFU as a minimally invasive quality-of-life-preserving treatment option.