Local Anaesthetic Transperineal Prostate Biopsies – Affordable and Simple
Prostate cancer is the commonest male malignancy and a leading cause of cancer related morbidity. In the UK, it represents 25% of all male neoplasms with an annual incidence of over 41,000 (1). Presently, the histological diagnosis is based on a transrectal ultrasound guided biopsy of the prostate (TRUSBx) under local anaesthesia (LA).
“DIPPING OUR NEEDLES IN FAECES”- ELIMINATING TRUSBx IN A COST EFFECTIVE WAY
The current method for diagnosing prostate cancer, the TRUSBx, requires a biopsy needle to pass through the bowel wall to reach the prostate. Bacteria in the bowel inevitably enter the urinary system and blood stream. A significant number of men develop infections despite preventative antibiotics.
1 in 10 develop fevers/shivers (2) 1-2 in 100 get a life-threatening infection (3). In the UK alone, tens of thousands of TRUSBx are performed annually, and this number will rise as the rate of suspected prostate cancer is set to increase by 69% by 2030 (4). Worryingly, the rates of infection are rising and there is evidence of increasing antibiotic resistance as a primary driver (5–6). Costs associated with UK hospitalisation episodes for biopsy-related sepsis alone are estimated to be £7–11 million annually (5).
It is crucial we find a safer biopsy method for suspected prostate cancer as over 1 million rectal biopsies occur each year world-wide.
Transperineal (TP) biopsy (TPBx) has significantly lower infective risks as needles traverse the sterilised perineum (the area under the testicles), and in fact, TPBx predate TRUSBx (7–8) Techniques using a perineal brachytherapy template grid under general anaesthesia (GA) or a free-hand ‘fan technique’ under local anaesthesia (LA) are both well established, although significant regional variations in practice exist (9). The use of GA and specialised equipment for grid-based TPBx limits its utility as a routine replacement for TRUSBx. Attempts at doing grid-based biopsies without GA have reported use of 50–60 ml of LA, additional analgesia and/or significant patient pre-preparation, which is not compatible with routine out-patient or office-based practice (10–11). The free-hand LA TPBx technique is appealing as it requires only two perineal punctures and no specialist equipment. However, the procedure is not standardised nor commonly performed in UK centres.
CamPROBE IS THE SAFE SIMPLE AFFORDABLE ALTERNATIVE
We sought a way to enable wider uptake of LA TPBx as a viable, cost-neutral and routine replacement for TRUSBx by developing the CAMbridge PROstate Biopsy DevicE (CamPROBE). CamPROBE biopsies are performed under local anaesthesia and taken through the perineum, so there is no infection risk, and it’s just as good at diagnosing prostate cancer as TRUSBx (12, 13, 14). We have already tested a prototype device where our results showed no infections or hospitalisations, and 79% of men preferred CamPROBE (Read our recently published pilot study here). There were no complications from the procedure and it took the same time as standard biopsies.
The CamPROBE is a cannulated TP access system based on the co-axial concept but bespoke to the context of prostate biopsies. The integrated device allows for synchronous device insertion and LA infiltration under ultrasound guidance, negating the need for separate punctures, nerve blocks or sedation. Once in position, standard 18G core-needle biopsies can be taken through the retained cannula. The developing world has the most prevalent incidences for TRUSBx-related infections and sepsis (15). These developing countries have scarce resources to fund expensive biopsy alternatives. The low-cost of CamPROBE makes it feasible to adopt the safer TPBx world-wide. A video of the procedure can be found on YouTube.
CLINICAL TRIAL AND ASSESSMENT
Our upcoming NIHR-funded study will assess CamPROBE’s ability to reduce infections from prostate biopsies and its usability as an alternative to the current standard biopsies.
- Sterile transperineal route with only 2 punctures
- Integrated LA delivery
- Reduced LA dose requirements
- Designed specifically for perineal anatomy
- Ergonomic design
- Easy-to-learn and well established biopsy method
- Compatible with cognitive or image fusion targeted biopsies
- Single-use, disposable device
- Low cost, equivalent to TRUS biopsy guides
- Compatible with any US system
- No specialised equipment required
Watch the training video to see how easily the CamPROBE method is to learn and how seamlessly compatible it is with currant standard biopsy equipment. You can also find the video on YouTube.
QUESTIONS? Contact us!
Project Manager: Hannah Brechka, PhD
Office Phone: +44 (0) 1223 763985
Chief Investigator: Mr. Vincent Gnanapragasam, BMedSci MA PhD FRCS FRCSEdUrol
The CamPROBE Pilot Study (NCT02375035) has been made possible through funding support from Health Enterprise East, The Addenbrooke’s Charitable Trust and infrastructure support through the Cambridge Biomedical Campus.
The upcoming CamPROBE study (NCT03609528) has been made possible through funding from the National Institutes of Health Research (NIHR) Invention for Innovation award and infrastructure support through the Cambridge Biomedical Campus.
- Cancer Research UK. Available from URL: http://www.cancerresearchuk.org/cancer-info/cancerstats/world/prostatecancer-world/
- Rosario DJ, Lane JA, Metcalfe C, Donovan JL, Doble A, Goodwin L, Davis M, Catto JW, Avery K, Neal DE, Hamdy FC. Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. BMJ. 2012 Jan 9;344:d7894.
- Anastasiadis E, van der Meulen J, Emberton M. Hospital admissions after transrectal ultrasound-guided biopsy of the prostate in men diagnosed with prostate cancer: a database analysis in England. Int J Urol. 2015 Feb;22(2):181-6.
- Mistry M, Parkin DM, Ahmad AS, Sasieni P. Cancer incidence in the United Kingdom: projections to the year 2030. Br J Cancer. 2011 Nov 22;105(11):1795-803.
- Batura D, Gopal Rao G. The national burden of infections after prostate biopsy in England and Wales: a wake-up call for better prevention. J Antimicrob Chemother. 2013 Feb;68(2):247-9.
- Carignan A, Roussy JF, Lapointe V, Valiquette L, Sabbagh R, Pépin J. Increasing risk of infectious complications after transrectal ultrasound-guided prostate biopsies: time to reassess antimicrobial prophylaxis? Eur Urol. 2012 Sep;62(3):453-9
- Barringer B. Carcinoma of the prostate. Surg Gynecol Obstet 1922; 34: 168–176.
- Grummet JP, Weerakoon M, Huang S, et al. Sepsis and ‘superbugs’: should we favour the transperineal over the transrectal approach for prostate biopsy? BJU Int 2014; 114: 384–388.
- Galfano A, Novara G, Iafrate M, et al. Prostate Biopsy: The Transperineal Approach. European Association of Urology and European Board of Urology. EAU-EBU Update Series 2007; 5: 241–249.
- Bass EJ, Donaldson IA, Freeman A, et al. Magnetic resonance imaging targeted transperineal prostate biopsy: a local anaesthetic approach. Prostate Cancer Prostatic Dis 2017; 20: 311–317.
- Smith JB, Popert R, Nuttall MC, et al. Transperineal sector prostate biopsies: a local anesthetic outpatient technique. Urology 2014; 83: 1344–1349.
- Guo L-H, Wu R, Xu H-X, et al. Comparison between Ultrasound Guided Transperineal and Transrectal Prostate Biopsy: A Prospective, Randomized, and Controlled Trial. Scientific Reports. 2015;5:16089. doi:10.1038/srep16089
- Takenaka A. et al. A prospective randomized comparison of diagnostic efficacy between transperineal and transrectal 12-core prostate biopsy. Prostate Cancer Prostatic Dis. 11, 134–8 (2008).
- Hara R. et al. Optimal approach for prostate cancer detection as initial biopsy: prospective randomized study comparing transperineal versus transrectal systematic 12-core biopsy. Urology. 71, 191–5 (2008).
- Bennett HY, Roberts MJ, Doi SA, Gardiner RA. The global burden of major infectious complications following prostate biopsy. Epidemiol Infect. 2016 Jun;144(8):1784-91. doi: 10.1017/S0950268815002885. Epub 2015 Dec 9.