以下是針對 Sonablate® 高強度聚焦超音波（HIFU）與局部治療（Focal Therapy）所進行之主要研究的摘要說明

Shoji S., Naruse J., Ohno S., et al. | Prostate Cancer and Prostatic Diseases | November 2024
Study Size: N = 240 (D’amico risk classification: ‘low’ = 51; ‘intermediate’ = 107; high = ’82’)
Median Age: 69 | Pre-HIFU Median PSA: 6.42 | Median Follow Up: 48 Mo.

This study was designed to evaluate the clinical results of high-intensity focused ultrasound (HIFU) with intraoperative prostate compression for patients with localized prostate cancer. Outcomes pointed to significant oncological control with minimal impact of sexual and urinary function.

Patients were included if they had prostate specific antigen levels of ≤20 ng/mL and clinically significant prostate cancer (CSPC) within the left or right half, or upper or lower half of the prostate. Focal therapy using HIFU with intraoperative prostate compression was administered to lesions visible on magnetic resonance imaging. All patients were followed up for at least 24 months.

Peretsman S., Emberton M., Fleshner N., et al. | World Journal of Urology | March 2024
Study Size: N = 1819
Median Age: 67 | Pre-HIFU Median PSA: 7.1 | Median Follow Up: 24 Mo.

The purpose of this systematic review with meta-analysis was to characterize cancer-control outcomes and complications following visually directed HIFU for focal treatment of PCa.
A total of eight observational studies with 1,819 patients followed over a median of 24 months were included.
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Summary evidence from these eight studies demonstrated that visually directed HIFU for focal treatment of localized prostate cancer was associated with a relatively low risk of complications and acceptable cancer control over medium-term follow-up.

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.

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.

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).