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    Transperineal biopsy for diagnosing prostate cancer

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    2 The diagnostic tests

    Clinical need and practice

    2.1 Prostate cancer is the most commonly diagnosed cancer in men in the UK (Cancer Research 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 so may require treatment, which includes radiotherapy, chemotherapy, surgery or a combination of these.

    2.3 NICE's guideline on prostate cancer: diagnosis and management 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 a 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

    CamPROBE (JEB Technologies)

    2.7 The CamPROBE is a cannulated transperineal access system designed specifically for prostate biopsies. It consists of an access needle or 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 phase with the ultrasound probe. It costs £35.00 and 2 devices per procedure are required. At the time of writing this guidance, CamPROBE does not have a CE mark and is therefore not available on the UK market for clinical use.

    EZU-PA3U device (Hitachi Medical Systems)

    2.8 The Hitachi EZU-PA3U is a reusable dedicated freehand needle positioning device. It can be attached to either the Hitachi 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. 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.

    PrecisionPoint (BXTAccelyon)

    2.9 The PrecisionPoint transperineal access system is a single use 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: one on the left and one 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 £200.00 and is a single use device.

    SureFire (Delta Surgical)

    2.10 SureFire 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 each of 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 £120.00. At the time of writing this guidance, SureFire is not available on the UK market.

    Trinity Perine Grid (KOELIS/Kebomed)

    2.11 The Koelis Trinity Perine 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. The device is compatible with the Koelis Sidefire Ultrasound probe. It costs £754.40 and can be reprocessed 100 times.

    UA1232 puncture attachment (BK Medical)

    2.12 The UA1232 metal puncture attachment 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. 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.