The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on cryotherapy as a primary treatment for prostate cancer in November 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 cryotherapy as a primary treatment 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. The risk of prostate cancer rises with age and it is rare in men younger than 50.
Treatment options depend on the stage of the cancer. Current treatments for localised prostate cancer include watchful waiting, radiotherapy, and radical prostatectomy.
Cryotherapy may be performed under general or spinal anaesthesia. A warming catheter is inserted into the urethra, to prevent it being damaged by the cold. Cryoneedles or probes are inserted into the prostate, under radiological guidance. Temperature monitor probes may also be placed percutaneously through the perineum. Argon gas or liquid nitrogen is then circulated through the needles or probes generating very low temperatures and causing the formation of ice around the prostate gland, which destroys the tissue. Newer cryotherapy techniques allow for these needles to be removed or repositioned so that the frozen zone conforms to the exact size and shape of the target tissue.
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.