focused. precise.

Clinical Data

on High Intensity Focused Ultrasound (HIFU)
A summary of the three major studies evaluating Sonablate® HIFU and Focal Therapy is detailed below.
Cancer Control Outcomes Following Focal Therapy Using High-intensity Focused Ultrasound in 1,379 Men with Nonmetastatic Prostate Cancer: A Multi-institute 15-year Experience

Reddy D., Peter M., Shah T.T., et al. | European Urology | February 2022
Study Size: N = 1379 | Median Age: 66 | Pre-HIFU Median PSA: 6.9
Follow Up: ≥6 Mo. | Median Follow Up: 32 Mo.

This study as published in European Urology reported on oncologic outcomes and adverse events following focal Sonablate high intensity focused ultrasound for treating nonmetastatic prostate cancer. The data was prospectively recorded in the HIFU Evaluation and Assessment of Treatment (HEAT) registry and included 1379 men with at least 6 months of follow up data. It is important to note that this study includes data from 13 UK centers and that 24% of the patients had at least five years of follow up, with some follow up going out as far as 15 years. This data shows the durability of outcomes for focal Sonablate HIFU and that successful programs can be implemented with multiple users.

Key Finding:

"Focal Sonablate HIFU in carefully selected patients with clinically significant prostate cancer, with six and three of ten patients having respectively, intermediate-and high-risk cancer, has good cancer control in the medium term."

Sonablate HIFU was the sole HIFU device used for treatments
Metastasis-free survival and prostate cancer-specific mortality at 7 years
Failure-free survival (FFS*) in intermediate-risk cancers at 7 years
Failure-free survival (FFS*) in high-risk cancers at 7 years
Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study

Shah T.T., Reddy, D., Peters, M., et al. | Prostate Cancer and Prostatic Diseases| January 2021
N = 492 patients
246 Radical Prostatectomy|246 Focal Therapy patients
(Sonablate HIFU and Cryotherapy)

Recently published in the Prostate Cancer and Prostatic Diseases, the authors of this study used prospective multi-center databases of 761 Focal therapy cases (626 Sonablate HIFU / 135 Cryotherapy) and 572 radical prostatectomy cases between November 2005 – 2018. After matching, 246 focal therapy patients and 246 radical prostatectomy were identified. The primary outcome was to determine differences in failure-free survival (FFS) between the focal therapy and radical prostatectomy cohorts.

Key Finding:

In patients with non-metastatic low- intermediate prostate cancer, oncological outcomes over 8 years were similar between focal therapy and radical prostatectomy."

Patients Matched On:
Treatment Year
Cancer Core Length
Use of Neoadjuvant Hormones
Gleason Score
Data Table
Patient-reported Satisfaction and Regret
Following Focal Therapy for Prostate Cancer: A
Prospective Multicenter Evaluation

Ghoreifi, A., Kaneko, M., Peretsman, S., et al. | European Urology Open Science| February 2023
N = 143 patient respondents|3 validated questionnaires during a post operative period of 26-68 months

There are several reports regarding decision satisfaction/regret for patients receiving conventional treatments (radical and active surveillance), however there was limited data about patients undergoing focal therapy. The authors’ main objective of this study was to evaluate the treatment decision satisfaction and regret among patients who underwent focal therapy for prostate cancer with high-intensity focused ultrasound (HIFU) or cryoablation (CRYO).

Key Finding:

"Focal Therapy using HIFU and CRYO for localized prostate cancer is well accepted by the patients, with a low regret rate."

HIFU Patients' response to each question of the Decision Regret Scale (%)
Clinical Bar Graph

Up to 25% of patients may experience regret following their conventional treatment; the most common factors associated with regret were treatment toxicity, urinary and particularly sexual, dysfunction.

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