FocalONE high-intensity focused ultrasound for localized prostate cancer: A systematic review of oncologic outcomes, functional preservation, and technological evolution.

INTRODUCTION

Focal therapy offers a middle-ground approach for localized prostate cancer, preserving the prostate while avoiding the morbidity of radical treatment. High-Intensity Focused Ultrasound (HIFU) is the most studied focal modality, with FocalONE representing the most widely adopted modern platform enabling precise image-guided ablation.

OBJECTIVE

To systematically assess the oncologic control, functional outcomes, safety, and technological advancements of focal and hemiablation HIFU with an emphasis on the FocalONE platform.

METHODOLOGY: This systematic review followed PRISMA guidelines and was registered in PROSPERO. A comprehensive search of PubMed, Embase, and Cochrane databases identified prospective studies using FocalONE or earlier-generation transrectal HIFU devices for focal or hemiablation in localized prostate cancer. Key outcomes included biopsy negativity, salvage-free survival, urinary continence, erectile function, and complications. Study quality was appraised using the JBI tool.

RESULTS

Five prospective studies involving 701 patients were included. Biopsy negativity ranged from 84% to 95%, with salvage-free survival reaching up to 92% at mid-term follow-up. Urinary continence was preserved in 96-100% of patients, and erectile function in 74-95%, with the most favorable functional outcomes consistently observed in FocalONE-based cohorts. Most adverse events were minor (grade I-II), with few serious complications. Compared to focal cryotherapy and irreversible electroporation, HIFU showed comparable cancer control and better or similar functional preservation. PSA density and MRI-visible lesions were strong predictors of success.

CONCLUSION

FocalONE-based focal HIFU provides effective cancer control with excellent functional preservation in selected patients. While evidence from earlier-generation devices supports these trends, generalizability across all HIFU platforms remains to be validated. Its precision and safety profile make it a promising alternative between active surveillance and radical therapies, especially in favorable intermediate-risk cases.