2 The procedure

2.1 Indications and current treatments

2.1.1 Prostate biopsy in patients with suspected prostate cancer is usually carried out by a transrectal needle biopsy. Amongst other uses, transperineal template biopsy may be used for patients with suspected prostate cancer who have had a negative or inconclusive transrectal biopsy.

2.1.2 The use of transperineal template biopsy of the prostate has also been proposed for other indications including mapping to determine the location and extent of prostate cancer as a guide to focal treatment (such as ablation); as part of active surveillance of low-risk localised prostate cancer with the aim of reducing the number of biopsies; and as a reference test for evaluation of new methods of imaging the prostate.

2.2 Outline of the procedure

2.2.1 This procedure is carried out with the patient under local or general anaesthesia, with intravenous prophylactic antibiotic coverage and a temporary urinary catheter. 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 defined parts of the prostate.

2.2.2 Template biopsy allows a large number of tissue samples to be obtained from different parts of the prostate. This may improve detection of small cancers compared with other biopsy methods. An aim of the transperineal approach is to reduce the risk of infection compared with transrectal biopsy.

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 .

2.3 Efficacy

2.3.1 A randomised controlled trial (RCT) of 246 patients investigated by 12-core transperineal biopsy or transrectal biopsy reported cancer detection rates of 42% (53/126) and 48% (58/120) respectively (p = 0.323). A case series of 373 patients reported that cancer was detected in 76% (60/79) of patients at first biopsy and in 34% (22/64) of patients with 3 or more previous negative biopsies.

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).

2.3.3 A case series of 747 patients reported adenocarcinoma detection in 39% (291/747) of patients; more frequently in apical compared with basal regions of the prostate (p < 0.001), and anterior rather than posterior regions (p = 0.036) (absolute figures not stated).

2.3.4 No evidence was found to support the efficacy of the procedure in active surveillance or for mapping as a guide to focal prostate cancer therapy.

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

2.4 Safety

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

2.4.2 The RCT of 246 patients investigated by transperineal 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 a catheter when discharged from hospital), 2% (6/371) (all 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.

2.5 Other comments

2.5.1 The Committee noted that there is considerable variation in the number of biopsy samples taken during the procedure.

  • National Institute for Health and Care Excellence (NICE)