1 Recommendations

Guidance

1.1 Evidence on the safety and efficacy of biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer is limited in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.

1.2 Clinicians wanting to do biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer should:

Inform the clinical governance leads in their healthcare organisation.
Give people (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.
Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.

1.3 Healthcare organisations should:

Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
Regularly review data on outcomes and safety for this procedure.

1.4 The procedure should only be done by clinicians with training in and experience of transperineal interventional procedures.

1.5 Further research could be in the form of randomised controlled trials or observational data studies including registry studies and real-world evidence. It should report details of patient selection, choice of radiotherapy technique and device used, improvement in quality of life, and long-term efficacy and safety. It should also identify high-risk groups who might benefit.