Interventional procedures consultation document - low dose rate brachytherapy for prostate cancer (second consultation)
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Low dose rate brachytherapy for localised prostate cancer
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:
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:
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
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.
|1.3||This procedure should be planned and performed by a multidisciplinary team. The Institute has issued a clinical guideline on services for urological cancers which is available from www.nice.org.uk/page.aspx?o=36469.|
|1.4||Further research and audit should address quality of life, clinical outcomes and long-term survival.|
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.
|2.2||Outline of the procedure|
Brachytherapy is a form of radiotherapy in which radiation is delivered directly to the prostate gland by small radioactive pellets (called seeds).
|2.2.2||Under general or spinal anaesthetic and ultrasound guidance, the seeds are inserted via needles passed through the skin of the perineum. In low dose rate brachytherapy the seeds are left in place permanently and give off radiation at a low dose over several weeks or months.|
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.
|2.3.2||However, a recent large cohort study comparing almost 3000 patients undergoing low dose rate brachytherapy (either as monotherapy or combined with external-beam radiotherapy) with external beam radiotherapy (> 72 Gy) or radical prostatectomy, found no difference in biochemical-recurrence-free survival between the three treatments at 5 or 7 years after treatment. In a comparative study in which 869 patients underwent low dose rate brachytherapy, a 0.5 ng/ml PSA nadir level was reached in 86% (748/869) of patients after therapy, although the number maintaining this level fell to 1% (10/869) at 5 years. However, no comparison of long-term effects could be made because the outcomes for radical prostatectomy patients were not recorded beyond 2 years.|
|2.3.3||In a comparative study involving 1819 patients, overall survival at median follow-up of 58 months in patients with T1 or T2 cancer was found to be similar among those undergoing low dose rate brachytherapy (93%; 679/733), radical prostatectomy (97%; 721/746) and external-beam radiotherapy (96%; 325/340).|
|2.3.4||In another study, physical function scores in 92 patients treated with low dose rate brachytherapy and 327 patients treated with radical prostatectomy showed no significant changes from baseline in either group at 24 months. For more details, refer to the sources of evidence (see Appendix).|
|2.3.5||The Specialist Advisors considered low dose rate brachytherapy to be an established procedure and stated that the results are comparable with those achieved with surgery or external-beam radiotherapy in well-selected patients.|
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)..
|2.4.3||The Specialist Advisors noted potential complications as radiotherapy toxicity, incontinence, infection and erectile dysfunction.|
|2.5.1||The data are difficult to interpret because of the other treatment modalities used alongside this procedure.|
|2.5.2||In recommending that further research and audit should address long-term survival, the Committee noted that men with prostate cancer often die from unrelated causes.|
|2.5.3||The Committee also noted that the appropriate length of long-term follow-up would depend on the stage and grade of the tumour.|
|3.1||The Institute has issued interventional procedure guidance on laparoscopic radical prostatectomy (www.nice.org.uk/IPG016guidance), high-intensity ultrasound for prostate cancer (www.nice.org.uk/IPG118guidance) and is preparing guidance on cryotherapy for recurrent prostate cancer (www.nice.org.uk/ip_130) and high dose rate brachytherpy (www.nice.org.uk/ip_305).|
Chairman, Interventional Procedures Advisory Committee
|Appendix:||Sources of evidence|
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
This page was last updated: 04 February 2011