High-Intensity Focused Ultrasound For Localized Prostate Cancer: Initial Experience With A 2-Year Follow-Up
Featured ArticleMain Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology; Cancer / Oncology; MRI / PET / Ultrasound
Article Date: 07 Jun 2009 - 7:00 PDT
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UroToday.com - The diagnosis of localised prostate cancer is increasing due to increased awareness and increased testing. There are a number of treatment options available to many of these men, including surgery, radiotherapy, active surveillance and a range of new modalities including high intensity focused ultrasound (HIFU).
- Large numbers of men with localised disease are looking for treatments that minimise their morbidity (continence and erectile function) whilst maximising oncological effectiveness.
- There is often significant initial enthusiasm for new technologies due to huge range of technological innovation in medicine today; however, treatments for localised prostate cancer need at least a 10 year follow-up to show efficacy over standard techniques.
- Much of this enthusiasm is generated by companies that have invested heavily in these new technologies and often market them aggressively, irresponsibly and unwisely with immature data. It is suggested that HIFU is morbidity-free with better oncological outcomes than traditional treatments.
- National medical bodies can also be drawn in by publicity; such as the National Institute for Clinical Excellence (NICE) in the UK, which initially supported HIFU but has subsequently changed its guidance and now recommend using it only within clinical trials.
- Early HIFU case studies showing promising results have been widely publicised generating more clinician awareness and interest, and proponents of this technique have gained notoriety presenting their data internationally.
- There is a huge publication bias in surgical trials as positive results have a much better chance of being published, are published earlier, and are published in journals with higher impact factors. Conclusions exclusively based on published studies, therefore, can be misleading and selective underreporting of research might be widespread and more likely to have adverse consequences for patients than publication of deliberately falsified data. This publication bias is likely to apply to HIFU.
- There is a significant lack of good quality outcomes and efficacy data as patients often refuse to enter randomised controlled surgical trials.
- In our hands, HIFU was unable to match traditional treatment modalities (minimally-invasive radical prostatectomy, external beam radiotherapy or brachytherapy) for oncological efficacy. In addition it generated significant and devastating complications in some patients.
- We would urge urologists against commencing a HIFU programme until high quality long-term data becomes available as we seriously question its safety and ability to cure localised prostate cancer.
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NICE And HIFU
posted by FERGUS MACBETH on 11 Jun 2009 at 8:41 amWe are interested to read that Dr Challacombe and colleagues share the view of the National Institute for Health and Clinical Excellence (NICE) that HIFU should currently not be used routinely in clinical practice for prostate cancer until better research results are available. But we would like to correct the statement that NICE ‘changed its guidance’.
The first assessment of HIFU was as a Interventional Procedure Guidance (http://www.nice.org.uk/nicemedia/pdf/ip/IPG118guidance.pdf ) which only looked at safety and efficacy. That advised that it was a procedure that could be used in the NHS ‘provided that the normal arrangements are in place for consent audit and clinical governance’. This guidance to the NHS is equivalent to the licensing of a pharmaceutical product.
Subsequently HIFU was looked at again as part of clinical guideline to determine whether it should be made routinely available in the NHS, and the evidence of comparative clinical and cost effectiveness was assessed. As a result guidance was issued which said that it should only be used in the NHS as part of ‘controlled clinical trials’ (http://guidance.nice.org.uk/IPG118 ). This is not a change of guidance -the second guidance amplified the first.
Fergus Macbeth, Director of Centre for Clinical Practice
Peter Littlejohns, Clinical and Public Health Director
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