Transperineal template biopsy of the prostate - Interventional Procedures Consultation Document

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Transperineal template biopsy of the prostate

The prostate is a small gland near a man's bladder. A test to collect a sample of tissue may be needed when there are concerns about possible prostate cancer.

Template transperineal biopsy involves the insertion of many fine needles through the skin between the scrotum and the anus in order to obtain tissue samples from the prostate for testing. The procedure is carried out with the patient under local or general anaesthesia.

The National Institute for Health and Clinical Excellence (NICE) is examining transperineal template biopsy of the prostate and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about transperineal template biopsy of the prostate.

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 provisional recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence, with bibliographic references where possible.

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

The process that NICE 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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

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

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 23 March 2010

Target date for publication of guidance: June 2010

 

1       Provisional recommendations

1.1  Current evidence on the efficacy of transperineal template biopsy of the prostate shows an increase in diagnostic yield in patients with suspected prostate cancer who have had negative or equivocal results from other biopsy methods. There are no major safety concerns. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.

1.2  Evidence was not found to support the use of transperineal template biopsy of the prostate as a mapping technique to determine the exact location and extent of prostate cancer, nor to support its use to guide focal ablation of prostate cancer. Therefore the procedure should be used with these intentions only with special arrangements for clinical governance, consent and audit or research.

1.3  Clinicians wishing to undertake transperineal template biopsy of the prostate as a mapping technique to guide focal therapy of prostate cancer should take the following actions.

·     Inform the clinical governance leads in their Trusts.

·     Ensure that patients and their carers understand the uncertainty about the procedure’s efficacy in localising prostate cancer and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]

·     Audit and review clinical outcomes of all patients having transperineal template biopsy of the prostate (see section 3.1).

1.4  NICE encourages further research on the use of transperineal template biopsy for mapping, by comparing the results with specimens obtained at prostatectomy. This will help to define the accuracy of the procedure in determining the location and extent of prostate cancer. 

2       The procedure

2.1    Indications and current treatments

2.1.1  Prostate biopsy in patients with a suspected diagnosis of prostate cancer is usually carried out by a transrectal needle biopsy. Transperineal template biopsy is intended primarily for patients with suspected prostate cancer who have had negative or inconclusive transrectal biopsy.

2.2    Outline of the procedure

2.2.1  The aim of transperineal template biopsy is to obtain a large number of tissue samples from all parts of the prostate gland. This may enable detection of small cancers. The transperineal approach also aims to reduce the risk of infection compared with transrectal biopsy. 

2.2.2  This procedure is carried out with the patient under local or general anaesthesia and intravenous prophylactic antibiotic coverage. A catheter is used to drain the bladder. A grid template with multiple holes approximately 5 mm apart is placed on the perineum. Under transrectal ultrasound guidance a biopsy needle is introduced through different holes in the template, to obtain biopsies from different parts of the prostate. The catheter is removed before patient discharge.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP793overview.

 

2.3    Efficacy

2.3.1  A randomised controlled trial (RCT) of 246 patients investigated by 12 core transperineal biopsies or transrectal biopsy reported cancer detection rates of 42% (53/126) and 48% (58/120) respectively (p = 0.323). There was no difference between these two biopsy approaches when their respective detection rates were compared for patient subgroups defined by prostate specific antigen (PSA) levels (significance not stated).  

2.3.2  A non-randomised controlled study of 135 patients reported greater Gleason score agreement between biopsy and final pathology for 12-core transperineal biopsy (70% [32/46]) compared with 6-core transrectal biopsy (49% [44/89]) (p = 0.013) (Gleason grade score ranges from 2 [normal appearance] to 10 [abnormal appearance]).

2.3.3  A case series of 747 patients reported adenocarcinoma detection in 39% (291/747) of patients; malignancy was detected more frequently in apical compared with basal regions of the prostate (p < 0.0001), and in anterior rather than posterior regions (p = 0.036) (absolute figures not stated).

2.3.4  A case report of 303 patients with raised PSA levels undergoing transperineal template biopsy reported that 38% (114/303) of patients were diagnosed as having prostate cancer, and 3% (8/303) as having intraepithelial neoplasia. Among patients with PSA levels between 30.1 and 70 ng/ml, 69% (26/38) had a positive biopsy; of those with PSA > 70 ng/ml, 100% (41/41) had prostate cancer.

2.3.5  The Specialist Advisers listed key efficacy outcomes as detection rate of prostate cancer (particularly apical tumours) and better localisation of tumour(s) within the gland.

2.4    Safety

2.4.1  The RCT of 246 patients biopsied by either transperineal or transrectal approach reported fever > 38.5°C in 0% (0/126) and 2% (2/120) of patients respectively (p = 0.136 (duration and follow-up not stated). Infection (not otherwise described) was reported in < 1% (1/747) of patients in the case series of 747 patients (follow-up not stated).

2.4.2  The RCT of 246 patients treated by transperineal prostate biopsy or transrectal prostate biopsy reported haematospermia in 2% (2/126) and 0% (0/120) of patients respectively (p = 0.166) (duration and follow-up not stated). 

2.4.3  Urinary retention was reported in 10% (77/747) (all required catheter at patient discharge), 2% (6/371) (all had haematuria and required overnight catheterisation), 2% (7/303) (not otherwise described) and 11% (24/210) (not otherwise described) of patients in case series of 747, 371, 303 and 210 patients.

2.4.4  The Specialist Advisers considered theoretical adverse events to include septicaemia, bleeding, urinary tract infection and haematuria.

3     Further information

3.1  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2  For related NICE guidance see www.nice.org.uk.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
February 2010

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 It is the responsibility of consultees to accurately cite academic work in order that they can be validated.

This page was last updated: 30 March 2010