JMIR Publications

ABSTRACT

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 prospective study evaluates longitudinal HRQoL trajectories and psychological outcomes in patients who met criteria for active surveillance but chose 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 68/11, AUO). All patients had concordant mpMRI and biopsy findings and underwent standardized unilateral HIFU. HRQoL was assessed at baseline and at 1, 3, 6, 9, and 12 months using the EORTC QLQ-C30 (version 3.0). Psychological distress was measured with the Hospital Anxiety and Depression Scale (HADS). Longitudinal changes were analyzed using linear mixed-effects models with false discovery rate correction. Outcomes were compared with German and Norwegian normative populations, and clinical relevance was interpreted using Osoba criteria.

Results:

Fifty-four patients were enrolled, of whom 51 completed 12 months of follow-up. Baseline HRQoL and functional scores were high, with low symptom burden. A clinically moderate but transient decline in global health status was observed at 1 month (mean 75 vs. 63; p=0.002, Cohen’s d ≈ 0.6), mainly driven by increased fatigue, pain, insomnia, appetite loss, and reduced physical, role, and social functioning. From month 3 onward, HRQoL returned to baseline or exceeded pretreatment levels and aligned closely with population norms, except for persistently mild constipation. Anxiety and depressive symptoms remained stable within the non-pathological range throughout follow-up. Overall psychological burden was low, and recovery trajectories were rapid.

Conclusions:

Focal HIFU hemiablation preserves long-term HRQoL and psychological well-being in carefully selected patients with localized PCa. Early postoperative impairment is temporary, and outcomes converge with normative population values within 3 months. These findings support focal HIFU as a quality-of-life–preserving treatment option for patients seeking minimally invasive therapy while avoiding overtreatment. Clinical Trial: Study Protocol AP 68/11, German Working Group on Urological Oncology (AUO)