Multicentre clinical evaluation of the safety and performance of a simple transperineal access system for prostate biopsies for suspected prostate cancer: The CAMbridge PROstate Biopsy DevicE (CamPROBE) study

Abstract

Objectives: To report the prospective multicentre clinical evaluation of a first-in-man disposable device, Cambridge Prostate Biopsy Device, to undertake local anaesthetic outpatient transperineal prostate biopsies. Material and methods: Disposable single-use Cambridge Prostate Biopsy devices were manufactured based on a previous prototype. The lead site developed a user training course and disseminated the method to other sites. The Cambridge Prostate Biopsy Device (CamPROBE) was offered as an alternative to transrectal ultrasound guided biopsy to men due for a biopsy as part of their clinical management. Data on safety (infections and device performance), clinical utility, patient reported experience, biopsy quality and cancer detection were collected. Procedure time and local anaesthetic use was recorded in the lead site. The study was funded by a United Kingdom National Institute for Health Research (NIHR) i4i product development award. Results: A total of 40 patients were recruited (median age 69 y) across six sites; five sites were new to the procedure. Overall, 19/40 were first prostate biopsies and 21/40 repeat procedures. Both image-targeted and systematic biopsy cores taken. There were no infections, device deficiencies or safety issues reported. The procedure was well tolerated with excellent patient-reported perception and low pain scores (median of 3, scale 0–10). Histopathology quality was good and the overall cancer diagnosis rate (first diagnostic procedures) was 68% (13/19) and for significant cancers (⩾ histological Grade Group 2), 47% (9/19). In the lead centre (most experienced), median procedure time was 25 minutes, and median local anaesthetic use 11 ml ( n=17). Conclusions: Data from this device evaluation study demonstrate that the United Kingdom-developed Cambridge Prostate Biopsy Device/method for transperineal biopsies is safe, transferable and maintains high diagnostic yields. The procedure is well tolerated by patients, suited to the local anaesthetic outpatient setting and could directly replace transrectal ultrasound guided biopsy. Level of evidence: Level III

Using Prostate Imaging-Reporting and Data System (PI-RADS) Scores to Select an Optimal Prostate Biopsy Method: A Secondary Analysis of the Trio Study

“…This study used transrectal biopsy to diagnose prostate cancer and these findings may not apply for transperineal biopsy, as a transperineal approach may provide superior access to the apical and anterior regions of the prostate. In addition, it has been shown that use of a transperineal approach results in a lower infection risk than a transrectal approach for prostate biopsy [37,38]. Similarly, MRI-visible lesions were not stratified on the basis of their zonal location within the prostate, which may have resulted in a better positive predictive value of MRI-targeted biopsy within certain prostate regions.…”

Economic Evaluation of Transperineal versus Transrectal Devices for Local Anaesthetic Prostate Biopsies

“…We developed a decision model comprising a decision tree with Markov models at the terminal nodes. Data informing the decision model were taken from a prospective case series representing the first rigorous data on the safety and acceptability of the CamPROBE [7], and other data from the literature to inform the likely cost effectiveness of the device, at various price points. We also conducted a value of information analysis (VoI) to guide the direction of further research to reduce uncertainty as to the cost effectiveness of TPUSBx devices.…”

“…These 'template biopsies' (making use of a grid placed over the perineum to guide needle insertion points) usually necessitate general anaesthesia (GA) with significant attendant costs. To overcome this, devices have been developed to permit transperineal biopsies (TPUSBx) to be performed under local anaesthesia (LA) and hence be more suited to the outpatient clinic setting [5][6][7]. To date however, it is not known how cost effective these devices are, especially given the relatively low cost and wide availability of the transrectal biopsy method.…”

“…Here we investigated the cost effectiveness of TPUSBx devices compared with TRUSBx in the diagnosis of prostate cancer in a UK secondary care setting from the perspective of the UK National Health Service (NHS). As a case study, we used the novel Cambridge Prostate Biopsy (CamPROBE) device, which has been recently evaluated for clinical effectiveness and safety [7]. The CamPROBE is based on the concept of a co-axial cannula, but designed specifically for transperineal prostate biopsies under LA.…”

“…Our base case assumed a zero risk of infection associated with TPUSBx. This was based on the prospective case series of 40 TPUSBxs from the recent CamPROBE published results [7].…”