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 for recurrent prostate cancer in May 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 for recurrent prostate cancer remains current, and should be read in conjunction with the clinical guideline.
This procedure is used to treat carcinoma of the prostate that has been unsuccessfully treated via another method, most typically radiation or hormones.
The procedure is performed by inserting cryotherapeutic probes into the prostate gland. These are used to freeze the gland along with cancerous tissue, thus destroying the diseased tissue.
Patients are typically given spinal anaesthesia. A warming catheter is inserted into the bladder, which is kept distended and warmed to 38º C and remains in place for two hours following the procedure. Cryoprobes are inserted into the prostate under transrectal ultrasonic guidance.
Thermocouples or temperature monitor probes are placed adjacent to the neurovascular bundles, the apex, Denonvilliers' space and external sphincter. A double freeze-thaw process is initiated with the anterior cryoprobes being activated first, followed by the posterior probes. The aim is to freeze the entire gland. A suprapubic tube is left in place and open for at least 4 days postoperatively.
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.