Clinical Trials 1. Hemi-ablation Study, Mr Mark Emberton, UCLH This is a clinical study looking at the possibility of treating one side of the prostate only; in men with disease on just one side.  Patients will be followed up to be sure that the cancer is treated successfully. It is expected that men will avoid significant  side effects such as erectile dysfunction by having just one side of the prostate treated.

2. Focal Ablation of Early Stage Prostate Cancer, Mr Mark Emberton, UCLH

This exciting study is examining the possibility of treating cancerous tumours on either or both sides of the prostate, whilst treating a minimum of healthy prostate tissue.  Men will be closely followed up to confirm that the cancer has been successfully treated.  Men should experience little or no side effects.

3. Prostate HIFU to treat patients who have failed radiotherapy, Mr Simon Brewster, Oxford Churchill.

This study will assess the outcome of prostate HIFU in men who have already been treated  by radiotherapy, but experience a recurrence of prostate cancer.  The study is only open to men who have cancer contained within the prostate.  It is expected that the side effects of treatment will be higher than men who have a primary HIFU treatment.  The centres involved in the study are;

1. Basingstoke - Mr Richard Hindley
2. Bristol - Mr R Persad and Mr D Gillatt
3. Derby - Mr Mike Henley
4. Glasgow - Professor Hing Leung
5. London - Mr M Emberton and Mr C Ogden
6. Oxford - Mr Simon Brewster

Focal Therapy with High-Intensity-Focused Ultrasound in the Treatment of Localized Prostate Cancer – Abstract

Monday, 25 February 2008

Department of Urology, Teikyo University School of Medicine, Tokyo, Japan.

We evaluated the efficacy and feasibility of high-intensity-focused ultrasound (HIFU) for localized prostate cancer.

Seventy patients received HIFU using Sonablate((R)) 500 (Focus Surgery, IN, USA). In patients whose cancer was confined to only one lobe by multi-regional biopsies, total peripheral zone and a half portion of transitional zone were ablated (focal therapy). Otherwise, patients received whole organ ablation (whole therapy). Scheduled biopsies were performed at 6 and 12 months after treatment. Pre- and post-HIFU serum testosterone levels were measured.

The 2-year biochemical disease-free survival (DFS) rates in patients at low, intermediate and high risk were 85.9, 50.9 and 0%, respectively, (P = 0.0028). After 12 months, 81.6% (40/49) of patients were biopsy negative; 84.4% in patients who received whole therapy, whereas 76.5% in those with focal therapy. The 2-year biochemical DFS rates for the patients at low and intermediate risk was 90.9 and 49.9%, respectively, in patients with whole therapy, whereas 83.3 and 53.6% in patients with focal therapy. In patients without neoadjuvant androgen deprivation, serum testosterone levels continuously decreased after whole therapy, whereas no changes were seen in those with focal therapy. The patients whose follow-up biopsies were positive tended to have significantly higher changes in prostate-specific antigen levels than biopsy-negative patients.

In patients with low-risk prostate cancer, HIFU monotherapy resulted in comparable immediate cancer control with other modalities. Particularly, focal therapy might offer a feasible minimally invasive therapeutic option, which maintained serum testosterone level. To our knowledge, this is the first report that whole, but not focal, therapy affects the serum testosterone level.

Written by
Muto S, Yoshii T, Saito K, Kamiyama Y, Ide H, Horie S.

Reference
Jpn J Clin Oncol. 2008 Feb 15. Epub ahead of print.
doi:10.1093/jjco/hym173

PubMed Abstract
PMID:18281309

Published Articles / White Papers

The following list is a collection of clinical data and research on HIFU available for download. Please contact us if you want more information or a copy of one of the papers below.

To download Acrobat reader - click here

Conduct of HIFU therapy for low to moderate risk, organ confined prostate cancer with the Sonablate R 500 system, result of consensus meeting ( 156 KB)
Authors: T A Leslie, R O Illing, J E Kennedy, J Calleary, L D D’Urso, L Mearini, S F Brewster, M Emberton

Sonablate R 500 – transrectal high-intensity  focused ultrasound for the treatment of
prostate cancer ( 4.34 MB)
Rowland Illing, Mark Emberton

EAU – Clinical Data Paper – Italian experiences, ‘Transrectal High Intensity Focused Ultrasound (HIFU), using the Sonablate 500 for the treatment of prostate cancer, the Perugia-Torino experience. (37 KB)
Mearini, L.1, D’urso, L.Z, Collura, C.Z Zucchi, A.1, Formiconi, A.2, Muto, M.2, Porena M.1
1. University of Perugia, Dept of Urology, Perugia, Italy, 20spedale, San Giovanni Bosco, Dept of Urology, Torino, Italy

Five years experience of transrectal high-intensity focused ultrasound using the Sonablate device in the treatment of localized prostate cancer (6.26 MB)

Sonablate -500: transrectal high-intensity focused ultrasound using the Sonablate device in the treatment of prostate cancer (4.34 MB )
Rowland Illing and Mark Emberton

Visually Directed HIFU for Prostate Cancer - A New Standard (227 KB)
Rowland O. Illing, Sam Dawkins, Chris W. Ogden and Mark Emberton. The Institute of Urology and Nephrology, University College Hospital, London, UK. The Clinical Effectiveness Unit, The Royal College of Surgeons of England, London, UK.

Transrectal High Intensity Focuses Ultrasound for treatment of patients with Stage Tib-2N0M0 localized Prostate Cancer: A Preliminary Report (1.37 MB)
Presentation of preliminary clinical results of transrectal HIFU in Stage T1b-2N0M0 prostate cancer. Dr. T Uchida, M.D.

Localized Prostate Cancer Treatment by High Intensity Focused Ultrasound (HIFU): Preliminary Results (32 KB)
Dr.T Uchida, M.D.

Noninvasive Surgery of Prostate Tissue by High Intensity Focused Ultrasound: An Updated Report (488 KB)
European Journal of Ultrasound.

Transrectal High Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer (663 KB)
T. Uchida, N. T. Sanghvi, T. Satoh, A. Irie,
T. Omata, S. Baba, M. O. Koch and T. A. Gardner

Perspectives in clinical uses of high intensity focused ultrasound (346 KB)
G.T. Clement Effect of High.

Intensity Focused Ultrasound (HIFU) on Human Prostate Cancer (375 KB)
Department of Urology, University of Vienna, Austria.

Will focal therapy become a standard of care for men with localized prostate cancer?
(867 KB)
Hashim Uddin Ahmed, Doug Pendse, Rowland Illing, Clare Allen,
Jan HP van der Meulen and Mark Emberton