Title: Perineal biopsy devices for diagnosis of prostate cancer in people with suspected prostate cancer (DAP57)
Funder: Department of Health and Social Care

Abstract: Prostate cancer is the most commonly diagnosed cancer in men in the UK. Around one in six males born after 1960 in the UK will be diagnosed with prostate cancer. Various procedures and tests can be used to investigate cases of suspected prostate cancer, such as blood testing to measure levels of prostate specific antigen (PSA) (increased PSA levels can indicate presence of cancer). The prostate itself may have felt abnormal during a digital rectal examination (a procedure in which a doctor inserts their finger into the person’s rectum so they can feel the prostate gland). Prostate cancer may be suspected if the prostate gland appears abnormal in shape and size on images taken during a multiparametric magnetic resonance imaging (mpMRI) test. Other risk factors may be taken into account such as whether there is any family history of prostate cancer. Information from the above tests and procedures can help inform the decision to do a prostate biopsy (the taking of small samples of the prostate using a biopsy needle) to diagnose prostate cancer._x000D_ _x000D_ During a prostate biopsy an ultrasound probe is placed in the rectum (back passage). The ultrasound probe uses sound waves to make an image of the prostate which is displayed on a small screen. The image helps the doctor move the biopsy needle to the correct location. Local anaesthetic is used to numb the area that the biopsy needle is passing through. The biopsy needle can either be inserted through the wall of the rectum (trans-rectal ultrasound [TRUS] method) or through the perineum (the skin area between the anus and the scrotum) in a transperineal prostate biopsy. Traditionally, most prostate biopsies in the NHS used the TRUS method but recently there has been a trend towards performing transperineal biopsy (particularly due to the COVID-19 pandemic)._x000D_ _x000D_ The aim of our research is to investigate whether the use of local anaesthetic transperineal (LATP) prostate biopsies gives an accurate diagnosis of prostate cancer, and whether the costs of LATP biopsy, and any cancer treatments then given, produce benefits to patients that are considered to represent an acceptable use of NHS resources (i.e. are they clinically effective and cost-effective?). Additionally, we will also examine if freehand transperineal biopsy devices that have been developed as aids to conducting LATP are a clinically and cost-effective use of NHS resources._x000D_ _x000D_ We will review all the relevant available research studies, using detailed systematic methods. We will examine how accurate LATP biopsies are to correctly detect prostate cancer and if there are any harmful effects from the biopsy. We will also look at how much LATP biopsy costs, per patient. To do this we will create a computersoftware based economic model to estimate the costs and benefits to patients and the NHS of LATP biopsies.

Lay abstract: The aim of this diagnostic assessment is to assess the clinical effectiveness and cost-effectiveness of LATP prostate biopsies performed using: a grid and stepping device, a double freehand approach or a freehand transperineal biopsy device, in people with suspected prostate cancer. The results will inform a NICE appraisal of the technology for use in the NHS.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: CANCER AND NEOPLASMS