Focused Ultrasound Shows Promise in Prostate Cancer Treatment Over 10-Year Study

Recent findings from two large registry studies indicate that high-intensity focused ultrasound (HIFU) could be a viable first-line treatment for localized prostate cancer. The Sonablate device was assessed over a decade, focusing on its effectiveness in delivering focal therapy, an organ-preserving treatment that targets only cancerous prostate tissue. The results, now published in European Urology, derive from the United Kingdom's HIFU Evaluation and Assessment of Treatment (HEAT) and the International Cryotherapy Evaluation (ICE) registries.

The research tracked outcomes in 3,477 patients treated across 14 UK centers. Of these, 2,897 patients underwent HIFU with the Sonablate device, while 580 received cryotherapy. Primarily, the study observed cancer-specific mortality rates, which stood at a low 0.13% after ten years. All-cause mortality was reported at 12%, with a metastasis rate of 3.3%. Approximately one-third of patients required additional local treatment, and 30% eventually received radical interventions. Notably, hormone therapy was needed less frequently in HIFU-treated patients (13%) versus those undergoing cryotherapy (21%).

The study's authors highlight the importance of careful patient selection for focal therapy, recognizing that approaches can differ significantly between institutions and countries. They urge the development of better patient selection methodologies and validated surveillance strategies.

Sonablate's representatives, including Chief Medical Officer Dr. Samuel Peretsman and Chief Science Officer Dr. Naren Sanghvi, celebrated the milestone study, noting the extensive collaboration and commitment that brought these findings to light. The HEAT registry, supported by Sonablate, is among the largest datasets of real-world clinical evidence for focused ultrasound technology.

Following the success of the HEAT registry, Sonablate has initiated the Sona Fusion Global Registry to broaden data collection and strengthen clinical evidence at leading centers worldwide. This initiative aims to accelerate the adoption of HIFU and improve outcomes for prostate disease patients globally.

Sonablate's HIFU technology was the first to receive FDA clearance for prostate tissue ablation in 2015 and is now approved in over 50 countries.