Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 10 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial, 1 meta-analysis, 1 health technology assessment, 4 systematic reviews, 1 review, 1 case series and 1 commentary. It is presented in the summary of key evidence section in the overview. Other relevant literature is in the appendix of the overview.

The professional experts and the committee considered the key efficacy outcomes to be: reduction in rectal toxicity, improvement in patient-reported outcome measures and quality of life.

The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, infection, need for spacer removal, rectal perforation and spreading malignant disease.

Twenty-two commentaries from patients who have had this procedure were discussed by the committee, as well as a submission from a patient organisation representing people who have had this procedure.

The committee was informed that there may be groups of patients who derive particular benefit from this procedure because they are at increased risk of developing severe symptoms of rectal toxicity after radiotherapy. This includes those with inflammatory bowel disease or on anticoagulation treatment. However, there was no published evidence to indicate which groups of patients benefited from this procedure.

The committee was informed that the incidence of rectal toxicity after radiotherapy has decreased over time with improvements in radiotherapy techniques.

The committee noted that there was a considerable amount of information from unpublished audits. NICE encourages publication of such data to allow it to be considered in future updates of this guidance.

The committee was informed that some spacers are radio-opaque and can be seen on CT, and these may reduce the need for MRI scanning.