1.1 Current evidence on focal therapy using cryoablation 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 cryoablation 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 cryoablation 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 cryoablation (including details of case selection, methods of follow-up and outcomes) for local audit. Clinicians should enter details about all patients undergoing focal therapy using cryoablation for localised prostate cancer onto the European Registry for Cryosurgical Ablation of the Prostate (EuCAP) register and review clinical outcomes locally.