- Outcomes from 3,477 prostate cancer patients in the UK who were treated with focal therapy and followed for up to 10 years have now been published.
- The findings represent one of the largest and longest evidence datasets in the field.
Sonablate recently announced the publication of 10-year outcomes from two registries—the United Kingdom HIFU Evaluation and Assessment of Treatment (HEAT) and the International Cryotherapy Evaluation (ICE)—evaluating long-term outcomes of focal therapy using high-intensity focused ultrasound (HIFU) or cryotherapy for localized prostate cancer. Focal therapy is an organ-preserving approach that treats only the cancerous portion of the prostate. The findings were published in European Urology.
The registries are nationally mandated United Kingdom–based data repositories that are managed by Focal Therapy UK.
The publication reports outcomes from 3,477 patients treated at 14 centers around the UK. Of the sample, 2,897 patients (approximately 83%) were treated with Sonablate® HIFU and 580 were treated with cryotherapy. Researchers tracked cancer-specific mortality rates as a primary outcome. Secondary outcomes were all-cause mortality, metastasis, local retreatment, radical treatment, and androgen-deprivation therapy (ADT) use.
After 10 years of follow-up, the registries demonstrated favorable long-term outcomes for patients treated with focal therapy using HIFU or cryotherapy. Cancer-specific mortality was 0.13%, and the all-cause mortality and metastases were 12% and 3.3%, respectively. One-third of patients required additional focal treatment (33%), while 30% ultimately underwent radical treatment. Furthermore, systemic ADT was required in 13% of HIFU patients compared with 21% of cryotherapy patients, highlighting a lower need for hormone therapy following HIFU treatment.
The authors concluded that the findings support focal therapy as a potential first-line treatment option in carefully selected patients. They also noted that “patient selection for focal therapy can vary considerably between institutions and countries,” so they recommended the development of improved patient selection tools, validated surveillance strategies, and prospective comparative effectiveness trials.
“These long-term outcomes provide important evidence demonstrating the potential of image-guided focused ultrasound to achieve durable cancer control while preserving quality of life,” said Samuel Peretsman, MD, Sonablate’s chief medical officer. “As the sponsor and long-term supporter of the HEAT Registry, Sonablate is proud to have contributed to one of the largest and longest real-world clinical evidence datasets ever published for a focused ultrasound technology platform.”
“This landmark publication represents far more than ten years of patient follow-up—it reflects more than twenty years of scientific vision, technological innovation and extraordinary physician collaboration,” said Naren Sanghvi, PhD, chief science officer at Sonablate Corporation. “Long before focal therapy became widely accepted, we believed prostate cancer treatment should deliver meaningful cancer control while preserving quality of life. Sonablate congratulates the study’s leading investigators, including Professor Hashim Ahmed, Professor Mark Emberton, Dr. Alexander Light, Dr. Taimur Shah, as well as the many physicians, researchers, clinical teams, participating hospitals and, most importantly, the thousands of patients whose commitment over two decades made this landmark study possible. Their collective work has helped transform focal therapy from an innovative concept into an evidence-based treatment option benefiting patients around the world.”
Based on the success of the UK HEAT registry, Sonablate launched another evidence-based database in May 2026 called the Sona Fusion™ Global Registry. This project’s goals are to expand long-term real world data collection across leading centers worldwide, further strengthen clinical evidence, accelerate physician adoption, and continue improving outcomes for patients with prostate disease (prostate cancer and BPH) across the globe.
In 2015, Sonablate was the first HIFU technology to receive US Food and Drug Administration clearance for prostate tissue ablation. Today, it is approved in more than 50 countries worldwide. Patients are encouraged to visit their website to find a treatment center or to learn more about the HEAT registry.
See European Urology (Open Access)
See the Sonablate Press Release
See Media Coverage by BBC and Independent
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