Focal Therapy Using High-Intensity Focused Ultrasound for Low- and Intermediate-Risk Prostate Cancer: Results from a...

Area of Science:

• Urology
• Oncology
• Medical Imaging

Background:

• Localized prostate cancer (PCa) treatments like surgery or radiotherapy can impair urinary and sexual function.
• Focal therapy aims to eradicate tumors while preserving healthy tissue.
• High-intensity focused ultrasound (HIFU) is an emerging focal therapy technique.

Purpose of the Study:

• To evaluate the oncological control, functional outcomes, and safety of MRI-guided focal HIFU for low- or intermediate-risk PCa.
• To assess the feasibility of focal HIFU as an organ-sparing treatment option.

Main Methods:

• Prospective, single-arm, phase II feasibility trial across three Austrian centers (2021-2024).
• Treatment-naive patients with low/intermediate-risk PCa received MRI-targeted focal HIFU (Focal One™).
• Primary endpoint: failure-free survival (FFS); Secondary endpoints: cancer recurrence, PSA levels, IPSS, IIEF, incontinence, and adverse events.

Main Results:

• At 24 months, 94.1% FFS was achieved, with only 5.9% requiring salvage radiotherapy.
• Follow-up biopsies showed no cancer in 83.9% of patients.
• Significant reduction in PSA levels, transient urinary retention in 21.6%, preserved erectile function, and minimal incontinence were observed.

Conclusions:

• MRI-guided focal HIFU demonstrates high two-year FFS with low morbidity in selected PCa patients.
• The technique preserves quality of life, including urinary and sexual function.
• Focal HIFU is a viable organ-sparing alternative to whole-gland treatment, warranting further investigation.