2 The diagnostic tests

Clinical need and practice

2.1 Prostate cancer is the most commonly diagnosed cancer in men in the UK. It mainly affects people over 50 and the risk is higher for people of African family background and people with a family history of prostate cancer.

2.2 Prostate cancer can be slow or quickly growing. If it is growing quickly, it is more likely to spread and may require treatment, which includes radiotherapy, chemotherapy, surgery or a combination of these.

2.3 The section on assessment and diagnosis in NICE's guideline on prostate cancer recommends that after someone is referred to secondary care with suspected clinically localised prostate cancer, they should be offered a multiparametric MRI (mpMRI) test. The results of this MRI should be reported using a 5‑point Likert scale. People with a Likert score of 3 or more should be offered an mpMRI-influenced prostate biopsy.

2.4 Prostate biopsies can be targeted using MRI to identify lesions to take a small number of tissue samples or cores from. Or they can be systematic, taking multiple samples from different regions of the left and right side of the prostate.

2.5 The current standard prostate biopsy is mpMRI-influenced local anaesthetic transrectal ultrasound (LA‑TRUS) biopsy or mpMRI-influenced local anaesthetic transperineal (LATP) biopsy. Both routes use a transrectal ultrasound probe inserted into the anus to image the prostate. Both approaches are done in an outpatient setting.

2.6 In a TRUS prostate biopsy, samples of prostate tissue are collected using a biopsy needle inserted through the rectal wall via the anus. The disadvantage of this method is that some people get serious infections, including sepsis, requiring hospital admission and antibiotics. In LATP biopsy, the needle enters the body through the perineum, the skin area between the anus and the scrotum. This could greatly reduce the risk of biopsy-related sepsis compared with a TRUS biopsy, and therefore may reduce hospital admissions and the need for preventative antibiotics.

The interventions


2.7 The CamPROBE (JEB Technologies) is a cannulated transperineal access system designed specifically for prostate biopsies. It consists of a coaxial cannula with an integrated needle. This needle can be attached to a standard syringe, allowing the device to be inserted and local anaesthetic to be injected at the same time under ultrasound guidance. This removes the need for separate punctures, nerve blocks or sedation. Once the cannula is in position, the integrated needle is removed and standard 18‑gauge core-needle biopsies can be taken through the retained cannula. CamPROBE is a disposable, single-use device that provides a transperineal biopsy route with only 2 puncture sites. The CamPROBE device does not attach to the ultrasound probe, so it requires a double freehand technique to manually keep the needle in line with the ultrasound probe. It costs £35, and 2 devices per procedure are required. At the time of writing this guidance, CamPROBE has a CE mark and is available on the UK market for clinical use.

EZU-PA3U device

2.8 The FUJIFILM EZU‑PA3U is a reusable dedicated freehand needle positioning device. It can be attached to either the FUJIFILM CC41R or the C41L47RP biplane transducer. The needle holder can be positioned on the vertical plane by sliding up or down before securing it into the required position. The needle holder is compatible with 14‑gauge or 18‑gauge needles. The company says that a coaxial needle can be used with the device. Needle targeting in the transverse plane is achieved by rotating the probe left or right until the needle trajectory is aligned with the lesion or area of interest. It costs £2,000 and is reusable.


2.9 The PrecisionPoint transperineal access system (BXTAccelyon) is a freehand needle positioning device that enables freehand LATP prostate biopsies in an outpatient setting. It uses the Perineologic 15‑gauge, 7 cm access needle, which is securely attached to the transrectal ultrasound probe via the PrecisionPoint needle guide. The guide comprises a clip and moving carriage with 5 vertical holes. The integral access needle is aligned with the ultrasound probe, so when the needle is inserted into the perineum it can be seen on the ultrasound image. The access needle typically requires only 2 entry points: 1 on the left and 1 on the right side of the anal verge. The biopsy needle can then be guided and directed to the relevant regions. The company says that the device is compatible with any biplane TRUS or transperineal probe from any ultrasound manufacturer. It costs £200 and is a single-use device.


2.10 SureFire (Delta Surgical) is a disposable freehand needle positioning device. It is designed to be used freehand without a stepper or stabilising device. It consists of a vertical needle guide with separate puncture channels at 9 different height settings, and an ultrasound probe clamp. The vertical needle guide can be rotated to reach different areas of the left and right side of the prostate, using the different height puncture channels. It costs £120. At the time of writing this guidance, SureFire was not available on the UK market and therefore was not considered by the committee in decision making.

Trinity Perine Grid

2.11 Trinity Perine (KOELIS/Kebomed) is a reusable freehand needle positioning device grid that attaches to an ultrasound probe for freehand transperineal biopsies under local anaesthetic. It consists of a vertical needle guide with 20 different height settings at 3 mm intervals, and an ultrasound probe clamp. There are 2 Perine Grids (18G and 14G). Each has a different needle gauge range. The 18G is compatible with 17‑gauge to 20‑gauge needles and the 14G is compatible with 14‑gauge to 16‑gauge needles. The company says that the Perine Grid can be used with a coaxial needle such as the BARD TruGuide disposable coaxial needle or equivalent. The device is compatible with the KOELIS Sidefire Ultrasound probe. It costs £754.40 and can be reprocessed 100 times.

UA1232 puncture attachment

2.12 The UA1232 metal puncture attachment (BK Medical) is designed for transperineal puncture and biopsy. It consists of a freehand needle positioning device and a mounting ring with a lock screw. The needle guide comprises 9 parallel guide channels, spaced 5 mm apart, each with an internal diameter of 2.1 mm suitable for a 14‑gauge needle. The company says that the choice of needle should be made by the clinician and the needle gauge should be compatible with the guide channel diameter. All parts of the puncture attachment can be sterilised by autoclave or disinfected by immersion in a suitable solution. The device is indicated for use with BK Medical ultrasound probes. It costs £1,400 and is reusable.

The comparators

2.13 The comparators are:

  • LA‑TRUS prostate biopsy

  • LATP prostate biopsy using a grid and stepping device

  • general anaesthetic transperineal (GATP) prostate biopsy using a grid and stepping device.

    Grid and stepping device-based biopsy approaches require the needle to pass through the perineum multiple times as the needle is passed through different holes in the grid to access different regions of the prostate. The grid is mounted on the stepping device, which is also used to hold and position the ultrasound probe.

  • National Institute for Health and Care Excellence (NICE)