The National Institute for Health and Clinical Excellence is examining low dose rate brachytherapy for localised prostate cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about low dose rate brachytherapy for localised prostate cancer.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows:

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 26 April 2005
Target date for publication of guidance: July 2005

Current evidence on the safety and short-term efficacy of low dose rate brachytherapy for localised prostate cancer appears adequate to support the use of this procedure, provided that the normal arrangements are in place for consent, audit and clinical governance.

Most evidence on the efficacy of low dose rate brachytherapy for localised prostate cancer relates to the reduction of prostate-specific antigen (PSA) levels and to biopsy findings. The effects on quality of life and long-term survival remain uncertain. Clinicians should ensure that patients understand these uncertainties and the alternative treatment options. Use of the Institute's Information for the public is recommended.

Treatment options for prostate cancer depend on whether the cancer is localised to the prostate gland. Current management options for localised prostate cancer include radiotherapy, radical prostatectomy and 'watchful waiting'.

Radiation therapy can take the form of external-beam radiotherapy or brachytherapy, or a combination of both. Brachytherapy may be given at either low or high dose rates. Low dose rate brachytherapy may be used alone (monotherapy) or in combination with external-beam radiotherapy.

Brachytherapy is a form of radiotherapy in which radiation is delivered directly to the prostate gland by small radioactive pellets (called seeds).

The literature search found no randomised controlled trials comparing low dose rate brachytherapy with other kinds of treatment, and few studies reported follow-up of more than 5 years. Evaluation of the effectiveness of brachytherapy is made difficult by the diversity of techniques used, the patient selection criteria applied, and the different follow-up intervals reported.

Complications were generally not well reported, but included irritative/obstructive urinary symptoms, rectal symptoms and sexual dysfunction. In one study involving 869 patients who had low dose rate brachytherapy, the impotence rate was 10-15%, compared with 45% in 208 patients undergoing radical prostatectomy. The incontinence rate was less than 1% in both groups.

Two case series included in a Health Technology Assessment Review reported disease-specific quality of life to be lower in patients receiving brachytherapy than in those receiving external-beam radiation therapy alone and those in a healthy population. However, this review did not differentiate between low dose rate and high dose rate brachytherapy. For more details, refer to the sources of evidence (see Appendix)..

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedures overview for low dose rate brachytherapy for localised prostate cancer, September, 2004

Available from: www.nice.org.uk/ip251overview