Key Points
- High-intensity focused ultrasound was used to treat more than 500 patients whose prostate cancer returned after radiotherapy.
- At 30 months after treatment, blood tests showed that durable cancer control was achieved.
The results from a large, prospective clinical trial evaluating the use of Focal One robotic high-intensity focused ultrasound (HIFU) as a salvage treatment for localized prostate cancer recurrence after radiotherapy were recently published in European Urology Oncology.
The multi-site French clinical trial, called HIFI-2 and sponsored by FocalTherics™*, enrolled 531 participants with a median age of 75 years over a 4-year period. Each patient had a biopsy-confirmed intraprostatic recurrence without metastases.
Following salvage HIFU treatment, participants’ prostate-specific antigen (PSA) levels decreased from a median of 4.5 ng/ml to 0.7 ng/ml 12 months after treatment. At 30 months, participants’ PSA levels rose slightly to 1.02 ng/ml.
The study’s primary endpoint was androgen deprivation therapy–free survival (ADT-FS), or the length of time a patient with prostate cancer lives without needing to start hormone-suppression therapies. Overall, the cohort achieved a 71% ADT-FS at 30 months after HIFU treatment. Importantly, participants whose pre-treatment PSA levels were less than the median of 4.5 ng/ml had better ADT-FS rates after treatment (84%). These data help underscore the importance of early detection of recurrent disease.
Serious adverse reactions were reported in 3% of participants only, and the number of cases with severe incontinence increased from 7% to 12% after HIFU treatment. Importantly, participants reported no deterioration in quality-of-life scores at 12 months.
“This large, prospective multicenter study demonstrates that salvage HIFU can achieve clinically meaningful oncologic control while maintaining an acceptable safety profile in patients with localized recurrence after radiotherapy,” said the first author of the publication, Guillaume Ploussard, MD, in the FocalTherics press release. “In a setting where treatment options offering curative intent remain elusive and often come with significant morbidity, these results are particularly meaningful. Combined with the growing body of clinical evidence, this study further supports HIFU’s transition toward becoming a standard of care for appropriately selected patients.”
*EDAP TMS formally changed its corporate name to FocalTherics™ in May 2026. The company’s flagship product brand remains Focal One.