Study in Lancet Oncology Shows Significant Side Effect Reduction With High Intensity Focused Ultrasound (HIFU) to Treat Prostate Cancer

CHARLOTTE, N.C., April 17, 2012 /PRNewswire/ -- A new treatment for prostate cancer using high intensity focused ultrasound (HIFU) to deliver focal treatment may provide an alternative to traditional treatment with significantly fewer side effects, according to results from a study published in the current issue of Lancet Oncology (DOI:10.1016/S1470-2045(12)70121-3). Incontinence and erectile dysfunction are common side effects of treatments for localized prostate cancer.

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In the research study "Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study," 42 patients received focal HIFU therapy delivered to clinically significant cancer lesions using the Sonablate^® 500 developed by US HIFU. The results showed that urinary and erectile function returned to pre-treatment levels 12 months after treatment.  None of the men who completed the trial had urine leak and just one in ten suffered from poor erections. Cancer control was encouraging although this was not the primary aim of the study. No biopsy evidence of cancer was identified in the treated regions in 30 of 39 men who were biopsied at six months and 36 of the 39 were free of clinically significant cancer. After re-treatment in four men, a total of 39 patients had no imaging evidence of disease at 12 months.

"We followed the HIFU treated patients for 12 months, evaluating the ability of this therapy to avoid side effects such as incontinence and erectile dysfunction," said Hashim Ahmed, MD, Clinical Scientist & Clinical Lecturer in Urology Division of Surgery and Interventional Science, University College London. "The results are very encouraging and warrant further study to demonstrate that focal therapy provides an alternative to traditional prostate cancer treatments with fewer side effects, which could mean a significant improvement in the quality of life for patients. We also need to test the medium and long term cancer control in multicenter comparative trials."

The majority of men treated for prostate cancer are treated with surgery or radiotherapy, which involve treating the whole prostate.  Both cause damage to the surrounding non-cancerous tissue and can lead to substantial side effects such as urinary incontinence and impotence.  The goal of focal therapy is to offer an alternative to men who value genito-urinary function and quality of life, allowing each patient and their physician to balance the risk and clinical benefit of individual treatment options.

The researchers previously used HIFU to treat the entire half of the prostate where cancer was found. That study also showed similar reduction in side-effects and encouraging early cancer control. In the focal HIFU study, researchers wanted to evaluate whether damage to healthy tissue could be further reduced by treating only the specific cancer sites in one or both sides. Results suggest that after focal therapy men have a 9 in 10 chance of achieving excellent clinical results at 12 months with no urine leak, good erections and no imaging evidence of disease.

"Tissue preserving strategies have been used successfully in other solid organ cancers, such as breast cancer. So, this highly targeted, precise acoustic scalpel technology represents a natural transition from treatment targeting the entire prostate to focusing treatment on the cancer," said Mark Emberton, MD, Director of the Division of Surgery and Interventional Science, University College London. "These results bolster previously published data that suggest that focal therapy offers harm reduction, which may offer a new option in a spectrum of care to treat prostate cancer based on risk profile and the balance of clinical benefits and quality of life."

HIFU is a therapy that destroys targeted tissue with rapid heat elevation. HIFU concentrates high frequency ultrasound waves (similar to a magnifying glass) into an area the size of a grain of rice. At that location, or focal point, the temperature rapidly rises to almost 90 degrees Celsius (195 degrees Fahrenheit).  Tissue at the focal point, including cancerous tissue, is destroyed. HIFU uses non-ionizing energy, so the procedure can be repeated, if necessary. HIFU is being studied around the world to treat a wide variety of cancers and soft tissue diseases.

"We are very encouraged by the results of this study which demonstrate how HIFU can be used to further refine the boundaries of the emerging field of focal therapy," said Mark Schoenberg, MD, Chief Medical Officer for US HIFU.  "These data provide support for the initiation of a larger trial to examine the role of focal therapy in the treatment of men with primary, organ-confined prostate cancer."

About USHIFU, LLC

USHIFU, LLC (US HIFU), a privately held, venture-backed healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US HIFU is committed to treating prostate cancer using HIFU with the Sonablate^® 500, a minimally invasive, outpatient procedure pioneered to control cancer and significantly improve patients' quality of life. US HIFU is engaged in ongoing research for technological advancements for the Sonablate system and/or other ultrasound applications. The Sonablate is approved for investigational use within the U.S. and is being studied in a clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with radiation therapy. The FDA has made no decision as to the safety or efficacy of the Sonablate for the treatment of prostate cancer. Currently, the device is available for the treatment of prostate cancer outside the U.S. in more than 30 countries. US HIFU was founded in 2004 and is headquartered in Charlotte, N.C. Additional information may be found at www.ushifu.com.

SOURCE USHIFU, LLC

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