Interventional Procedures Consultation Document - Brachytherapy for localised prostate cancer (first consultation)
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Brachytherapy for localised prostate cancer
The National Institute for Clinical Excellence is examining 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 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).
Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.
Current evidence on the safety and efficacy of brachytherapy for localised prostate cancer appears adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance.
|1.2||Most evidence on the efficacy of brachytherapy for localised prostate cancer relates to 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 therefore ensure that patients understand the uncertainties and the alternative treatment options. Use of the Institute's Information for the Public is recommended.|
|1.3||Further research and audit should address quality of life, clinical outcomes, and long-term survival.|
Carcinoma of the prostate is a malignancy initially localised within the prostate gland. It may spread to adjacent tissue or to bones.
|2.1.2||Treatment options for prostate cancer depend on whether the cancer is localised to the prostate gland. Current primary treatments for localised prostate cancer include 'watchful waiting', radiotherapy and radical prostatectomy.|
Radiation therapy uses high-energy rays or particles to kill cancer cells. It can take the form of external-beam radiotherapy or internal radiation therapy (brachytherapy). 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 ultrasound guidance, the seeds are inserted via needles passed through the skin of the perineum. They can be left in place permanently or, when high doses are used, removed after treatment.|
|2.2.3||When implanted permanently, the seeds give off radiation at a low dose over several weeks or months. High-dose brachytherapy involves inserting thin plastic catheters, using a template, through the perineal skin and into the prostate gland. The length of time a seed remains in each catheter is controlled so that the radiation dose is targeted effectively. The catheters are then removed, leaving no radioactive material in the prostate gland.|
Evaluation of the effectiveness of brachytherapy is made difficult by the diversity of techniques and patient selection criteria used, and the differing follow-up intervals. The literature search found no randomised controlled trials comparing brachytherapy with other kinds of treatment, and few studies reported follow up of more than 5 years. For more details, refer to the sources of evidence (see Appendix).
|2.3.2||A recent large cohort study comparing almost 3000 patients undergoing brachytherapy (either as monotherapy or combined with external-beam radiotherapy), 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 brachytherapy, a 0.5 ng/ml PSA nadir level was reached in 86% (748/869) of patients after therapy, although the number retaining this level fell to less than 1% (10/229) at 5 years. However, no comparison of long-term efficacies could be made because the outcomes for radical prostatectomy patients were not recorded beyond 2 years. For more details, refer to the sources of evidence (see Appendix).|
In a 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 brachytherapy (93%; 679/733), radical prostatectomy (97%; 721/746), and external-beam radiotherapy (96%; 325/340). For more details, refer to the sources of evidence (see Appendix).
|2.3.4||In another study, physical function scores in 92 patients treated with 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 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 brachytherapy, the impotency rate was 15% and the incontinence rate was less than 1% (median follow up 3 years). For more details, refer to the sources of evidence (see Appendix).
|2.4.2||Grade 4 toxicity (acute and late toxicity as defined by the Radiation Therapy Oncology Group guidelines) was reported in one case series to have affected 2% (1/43) of patients with stage T1 to T4 localised prostate cancer undergoing brachytherapy. However, in another study no instances of grade 4 toxicity were observed in 230 patients treated for T1 to T3 tumours. Two case series included in the Health Technology Assessment Review reported disease-specific quality of life to be lower in patients receiving brachytherapy than in those undergoing standard treatments and in a healthy population. For more details, refer to the sources of evidence (see Appendix).|
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 variation in doses used and 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.|
|3.1||The Institute has issued guidance on services for urological cancers including prostate cancer (www.nice.org.uk/page.aspx?o=36469). The Institute has also issued interventional procedure guidance on laparoscopic radical prostatectomy (www.nice.org.uk/IPG016guidance), and is preparing guidance on high-intensity ultrasound for prostate cancer (www.nice.org.uk/ip_230) and salvage cryotherapy for recurrent prostate cancer (www.nice.org.uk/ip_130).|
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 procedure overview for brachytherapy for localised prostate cancer, September 2004
Available from: www.nice.org.uk/ip251overview
This page was last updated: 04 February 2011