The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on high-intensity focused ultrasound for prostate cancer in March 2005.
Further recommendations have been made as part of the clinical guideline on prostate cancer published in February 2008, as follows:
High intensity focused ultrasound (HIFU) and cryotherapy are not recommended for men with localised prostate cancer other than in the context of controlled clinical trials comparing their use with established interventions.
Clinical and cost-effectiveness evidence was reviewed in the development of this guideline which has led to this more specific recommendation. More information is available from NICE guideline CG58. The IP guidance on high-intensity focused ultrasound for prostate cancer remains current, and should be read in conjunction with the clinical guideline.
Cancer of the prostate gland may cause it to enlarge, resulting in symptoms such as difficulty in urinating, frequent urination, and blood in the urine.
Treatment options depend on the stage of the cancer. Current treatments for localised prostate cancer include watchful waiting, radiotherapy, and radical prostatectomy. Metastatic prostate cancer is usually treated with hormone therapy.
High intensity focused ultrasound (HIFU) for prostate cancer is carried out under a spinal or general anaesthetic. With the patient lying on his right side, an endorectal probe incorporating an ultrasound scanner and a HIFU treatment applicator is inserted. This allows the target area to be monitored and defined before being treated. The probe emits a beam of ultrasound, which is focused to reach a high intensity in the target area. Absorption of the ultrasound energy creates an increase in temperature, which destroys the tissue within the focal area. A cooling balloon surrounding the probe protects the rectal mucosa from the high temperature. A urethral or suprapubic catheter is used after the procedure.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.