New ultrasound therapy for prostate cancer available9/9/2005A novel, non-invasive treatment for prostate cancer is announced today by UKHIFU. High intensity focused ultrasound (HIFU) therapy ris used to treat patients diagnosed with localised, early-stage prostate cancer. UKHIFU has been established to bring the benefits of HIFU technology to cancer sufferers and their families across the UK and Ireland. 
The therapy is made possible by the Sonablate 500 system, a medical device manufactured by thre US corporation Focus Surgery Inc., which is exclusively represented by UKHIFU. The HIFU energy is focused sharply from the transducer surface to the targeted tissue in the prostate. Temperature is elevated in the targeted tissue up to 90 degrees C within one second, causing cell death.
"For a prostate cancer therapy to be successful, it needs to be able to destroy the diseased tissue within the prostate (men have prostate cancers rather than prostate cancer)," Nick Stevens, Managing Director of UKHIFU explains, "and at the same time, preserve the vital structures around the gland that are involved in normal bladder emptying, preservation of continence and preservation of erectile and orgasmic function. Now the urologist can plan the treatment under ultrasound image guidance, target the prostate and monitor the therapy, all using a single transducer and probe that is part of the Sonablate 500 system," Stevens says. "This design provides maximum precision, flexibility, safety and control for the clinician."
Time for patient recovery after HIFU treatment is said to be significantly less than other therapies like radical prostatectomy. Recovery involves wearing a simple self managed catheter for a short period of time after treatment, and patients typically return to a normal lifestyle almost immediately after the 2 - 3 hour procedure. It is very much a same-day or out patient programme. HIFU treatment can also be safely repeated if necessary, and even added as a therapy by those patients who have experienced recurrence after being treated with an alternative therapy such as radiation therapy, including brachytherapy and cryotherapy.
The Sonablate 500 has approval in Europe for the treatment of prostate diseases (including prostate cancer, benign prostatic hyperplasia and prostatitis). There are currently 35 units being used in medical institutions around the world.
Recent studies in Europe have shown that in 88% of the patients studied, HIFU technology produced PSA measurements below 1.0 within one year following treatment, as well as lower incidence of erectile dysfunction (ED) and urinary incontinence (UI) than reported in studies of other therapies.
In total, nearly 1,400 patients worldwide have been treated with the Sonablate 500 for localized prostate cancer, with a 94% success rate in prostate cancer (as defined by ASTRO guidelines: negative biopsies with three successive prostate specific antigen (PSA) rises of less than 0.75ng/ml) for patients with PSA less than 10ng/ml pretreatment).
The Sonablate system concept for the treatment of prostate tissue has been validated through numerical computer simulations, laboratory measurements, in-vitro tissue experiments, in-vivo animal model measurements, and, most importantly, many clinical trials and clinical procedures around the world (under local and national regulatory approvals). The test procedures used during the manufacturing activities of the device have also been validated and shown to be appropriate to ensure its correct operation.
The first UK treatment using the Sonablate system was successfully performed in October at the Princess Grace Hospital by Mr Mark Emberton, Senior Lecturer in Oncological Urology / Honorary Consultant Urologist at the Institute of Urology and Nephrology of the Royal Free and University College London School of Medicine, University College London. Emberton is also the Clinical Director of the Clinical Effectiveness Unit, Royal College of Surgeons.
In a recent letter to Urology Surgeons and Clinical Oncologists, Emberton announced a European multi-centre study to evaluate the use of HIFU sponsored by the Sonablate's main European distributor, Misonix Inc. The UK will have two participants: The Institute of Urology at UCL and Churchill Hospital, Oxford, where the lead investigators will be Mr. Emberton and Mr. Simon Brewster respectively. This Phase II study will offer HIFU to a clearly defined population with the aim of characterising patient acceptability, side-effect profile and to determine efficacy of the therapy.
