1.1 Current evidence on focal therapy using high-intensity focused ultrasound (HIFU) for localised prostate cancer raises no major safety concerns. However, evidence on efficacy is limited in quantity and there is a concern that prostate cancer is commonly multifocal. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake focal therapy using HIFU for localised prostate cancer should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and their carers understand the uncertainty about the procedure's efficacy and the risks (specifically the risk of sexual dysfunction), and provide them with clear written information. In addition, the use of NICE's information for patients (Understanding NICE guidance) is recommended.
1.3 Patient selection and treatment should be carried out by a multidisciplinary urological cancer team.
1.4 NICE encourages further research into focal therapy using HIFU for localised prostate cancer. This should take the form of controlled studies comparing the procedure against other forms of management. Studies should clearly define patient selection criteria and should report outcomes including local recurrence in the long term.
1.5 Clinicians should collect data on all patients undergoing focal HIFU (including details of case selection, methods of follow-up and outcomes) for local audit and for submission to national and/or international registers when these become available. The European Registry for Cryosurgical Ablation of the Prostate (EuCAP) register is being developed to receive data on focal therapy using HIFU for localised prostate cancer. When this facility is available clinicians should submit data on all patients undergoing focal therapy using HIFU for localised prostate cancer to that register.