HIFU Offers Cancer Control, Fewer Adverse Events After Radiation

Radiation therapy (RT) followed by salvage high-intensity focused ultrasound (S-HIFU) demonstrated promising androgen deprivation therapy–free survival (ADT-FS) and functional outcomes in patients with local prostate cancer recurrence, according to a prospective study (NCT04307056) conducted across 32 centers in France.

In the overall cohort, ADT-FS was 71% (95% CI, 67%-76%) at 30 months. Patients with a pre–S-HIFU prostate-specific antigen (PSA) level of 4.5 ng/mL or less and a Gleason score between 6 and 7 had the most favorable ADT-FS rate of 84% (95% CI, 78%-91%) at 30 months, Ploussard et al, reported in European Urology Oncology.

“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,” Guillaume Ploussard, MD, PhD, first author and staff physician at CHU Saint-Louis, Assistance Publique Hôpitaux, Paris, stated in a news release.

Study Design

A total of 3328 patients were enrolled, with 1967 receiving HIFU and 1361 undergoing radical prostatectomy (RP); 531 patients from the broader cohort were evaluated in this analysis. Eligible patients had localized, low- to intermediate-risk prostate cancer, clinical stage T1 to T2 NxM0 disease, and a PSA of 15 ng/mL or less. Patients were not candidates for active surveillance and had a Gleason score of 3+4 or less. HIFU was restricted to patients older than 69 years with at least a 5-year life expectancy.

The primary end point was ADT-FS at 30 months. Secondary end points included local prostate cancer-specific survival, overall survival, and functional outcomes at 12 months. The non-inferior salvage treatment-free survival rate at 30 months was 90% for patients who received HIFU compared with 86% for those who received RP.

Patient Characteristics

Baseline characteristics were balanced between the HIFU and RP arms. Median PSA was 7.1 (range, 5.2-9.1) in the HIFU arm versus 6.9 (range, 5.4-9.1) in the RP arm. In the HIFU arm, 39% of patients had a low D'Amico risk score and 60% had an intermediate score. In the RP arm, those proportions were 36% and 63%, respectively.

Secondary Outcomes

Patients who received HIFU had favorable outcomes for both urinary continence and erectile function. The International Continence Society index showed significantly less deterioration with HIFU (29%) than with RP (44%) across all ages (relative risk, 0.66; 95% CI, 0.59-0.74; P <.001). The International Index of Erectile Function was also significantly less reduced at 12 months after HIFU compared with RP, with a difference in medians of
–3.0 (–3.9 to –2.1) between the 2 groups.

Investigators reported low rates of severe complications, an acceptable safety profile, and no significant deterioration in quality of life at 12 months.

“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,” Ploussard said.

Ryan Rhodes, chief executive officer of EDAP TMS, added that the study “marks an important milestone for the field of focal therapy and reinforces the clinical value of Focal One Robotic HIFU in addressing unmet needs in a growing spectrum of prostate conditions,” noting that the findings support Focal One as a non-invasive, organ-sparing option for patients facing recurrence after radiotherapy.

REFERENCES

1. Ploussard G, Coloby P, Chevallier T, et al. Salvage high-intensity focused ultrasound for prostate cancer recurrence after radiotherapy (HIFI-2 Study). Eur Urol Oncol. Published online April 28, 2026. doi:10.1016/j.euo.2026.04.007

2. EDAP TMS strengthens market position with landmark HIFI-2 data supporting Focal One robotic HIFU in radiorecurrent prostate cancer. News release. Accessed April 30, 2026. https://tinyurl.com/8ktnus4m