Multicentre clinical evaluation of the safety and performance of a simple transperineal access system for prostate biopsies of suspected prostate cancer: The CAMbridge PROstate Biopsy DevicE (CamPROBE) study.
Objectives: To report the prospective multicentre clinical evaluation of a first in man disposable device (CamPROBE) to undertake local anaesthetic outpatient (LA OPD) transperineal (TP) prostate biopsies. Material and methods: Disposable single-use CamPROBE devices were manufactured based on a previous prototype. The lead site developed a user training course and disseminated the method to other sites. CamPROBE was offered as an alternative to transrectal ultrasound guided biopsy (TRUSBx) 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 LA use was recorded in the lead site. The study was funded by a UK National Institute for Health Research i4i product development award. Results: 40 patients were recruited (median age 69y) across 6 sites, 5 were new to the procedure. 19/40 were first prostate biopsies and 21/40 repeat procedures with 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 overall cancer diagnosis rates (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 LA use 11mls (n=17). Conclusions: Data from this device evaluation study suggest that the UK developed CamPROBE device/method for TP biopsies is safe, transferable and maintains high diagnostic yields. The procedure is well tolerated by patients, suited to the LA OPD setting and could potentially directly replace TRUSBx.