Title: Developing a safer device for biopsies of suspected prostate cancer: The Cambridge Prostate Biopsy Device: CAMPROBE
Funder: Department of Health and Social Care

Abstract: The project will have 2 phases with distinct work packages and defined deliverables: Phase 1 (months 0-17) - Development of the disposable CAMPROBE, risk assessment, clinical study set-up and regulatory approvals. Development of the CAMPROBE device and instructional materials JEB engineering (Akehurst) and the clinical team (Gnanapragasam/Stone) will meet regularly to specify design, materials and product build using the existing prototype as a template. Design iterations will continue until a satisfactory device has been drafted. Following design freeze JEB will produce a device ready for the clinical trial. A project manager will be recruited in the first months. During this phase we will also produce instructional material (written & video) to train new users in the CAMPROBE biopsy method (Gnanapragasam/King). Deliverables: Designed and built CAMPROBE Production of instructional materials Device risk assessment, regulatory approvals, set-up of clinical study The new device will be evaluated as part of a managed design process and risk assessment applying ISO standards 14971&62366 (Stone). Methods including FMEA (failure modes and effects analysis) and FAST (function analysis system technique) as well as process simulations (e.g. Healthcare Design Tool Kit, Cambridge University Engineering Design Centre) will be employed. The knowledge of risk and usability will allow a managed iteration of the design that will inform the final device build and technical file to be submitted for MHRA approval. MHRA submission will be followed by ethics application for a clinical study (Gnanapragasam/CTU). The study protocol and ethics will be prepared in parallel with device testing to avoid delays. Following regulatory approvals (estm. month 14) the clinical study will be set up by the Cambridge Clinical Trials Unit (CTU). JEB will pack and sterilize devices in readiness. Any new IP generated will be registered and the device landscape re-analysed (Donald). Deliverables: Risk assessed clinic ready device Regulatory approvals achieved Clinical study sites set-up Phase 2 (18-33 months) – Clinical cohort study and health economic (HE) evaluation. Prospective cohort study evaluating CAMPROBE device and biopsy method, comparative HE evaluation The clinical study will start in Cambridge with simultaneous training of the Peterborough team (Sut) (hands-on & using instruction material). Patients will be recruited from prostate clinics (Gnanapragasam/Sut). Eligible men will be offered a CAMPROBE biopsy as an alternative to a standard biopsy. Outcomes (Day 0, 7 and 30 – recording complications and patient perceptions) will be assessed by validated questionnaires previously used in our pilot study. Besides recruitment and questionnaires, no additional visits or treatments are needed and patients will resume standard of care after biopsies. The target accrual is 40 (to detect a minimum 20% reduction in infections compared to the published literature with 80% power, p Deliverables: Completion of clinical study and data collection Cost utility analysis of CAMPROBE vs standard biopsies Analysis of results and outcomes (34-36 months) Results from the project will inform the final decision to volume manufacture, CE technical file submission, registration of IP and source follow-on funding. Study results will be disseminated to medical and lay audiences. Deliverables: Volume manufacture decision and CE mark application Integrated global assessment of the CAMPROBE device and method Dissemination of results

Lay abstract: The current method for diagnosing prostate cancer is with a biopsy (getting a tissue sample) of the prostate guided by an ultrasound probe inserted into the rectum (over 1 million performed each year in Europe and the USA). This procedure requires the biopsy needle to pass through the bowel wall to reach the prostate. Inevitably, this can result in bacteria in the bowel entering the urinary system and blood stream. Not surprisingly, a significant number of men develop infections despite preventative antibiotics (10% develop fevers and shivers and 1-2% will get a life-threatening infection). A safer alternative is to biopsy the prostate through the skin under the scrotum (testicles) known as the perineum (transperineal biopsies). This approach results in almost no infections and is just as good at diagnosing prostate cancer. This method however requires multiple punctures (going through skin and muscles) which is painful and men need a general anaesthetic to have it done. We have developed the CAMPROBE (Cambridge Prostate Biopsy Device) that replicates the safer transperineal biopsy approach but can be performed with local anaesthetic. To date we have made a prototype device and have tested it in our centre. Our results have been very encouraging with no infections or hospitalisations and 79% of men preferred it to the current standard approach. In this project we want to progress from a prototype to a fully developed disposable device that can be used by any UK hospital. We are seeking funds to build the device and then retest it again in our centre and another hospital to confirm our initial encouraging results. In addition, we will calculate the potential costs of using the CAMPROBE versus the current standard and balance this against the benefits to estimate the likely cost-effectiveness to the NHS.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS