Title: A study to assess the clinical and cost-effectiveness of the Ibex Artificial Intelligence Histology system in diagnosing clinically important prostate cancer on prostate biopsy tissue
Funder: Department of Health and Social Care

Abstract: Background About 80,000-100,000 men every year undergo prostate biopsy to diagnose prostate cancer, equating to 4 million histology slides. This is predicted to double by 2030. Combined with a pathology work-force shortage, and variability in pathology reporting, an artificial intelligence (AI) tool might be beneficial to the NHS. The Ibex-AI histology system has shown high sensitivity and specificity in other healthcare settings. Aims To determine the clinical and cost-effectiveness of the Ibex-AI system in ruling-out and detecting clinically important prostate cancer on scanned images of pathology slides processed in NHS hospitals. Plan The pathology slides from 600 men will be prospectively scanned at high resolution for the Ibex-AI system to analyse in parallel to the pathology review. Both will be blinded to the findings of the other. Discordant slides will be reviewed by 3 independent expert uro-pathologists with immunocytochemistry. We will assess sensitivity, specificity, negative and positive predictive values of Ibex-AI in detecting and ruling-out any Gleason 3+4=7 prostate cancer as well as any cancer and other thresholds of clinical importance based on grade and length of cancer. Timelines for Delivery Our proposal is for 2 years. In the 3 months prior to starting, we will draft trial documents. Regulatory approvals and site set-up will occur in the first 3-4 months and recruitment start by month 5. The calibration study will be conducted over 4 months. The validation study will recruit from 6 sites over 14 months, leaving 2 months for data analysis and final report. Anticipated Impact and Dissemination We will present our findings at conferences and publish in high impact journals. We will share results with trial participants and key stakeholders like patient support groups, charities, policy makers and professional medical groups. Our findings will inform clinical guidelines.

Lay abstract: Aims To determine the accuracy of a new artificial intelligence (AI) tool, the Ibex-AI system, in ruling-out and detecting clinically important prostate cancer on tissue taken during a prostate biopsy. To evaluate the costs associated with introducing the Ibex-AI system into NHS hospitals, and potential cost savings as well as cost-effectiveness. Background Every year, pathologists use a microscope to look at about 4 million glass slides holding tissue samples from 80,000-100,000 men. This creates some issues in the NHS. First, there is a shortage of expert pathologists. Second, the number of men biopsied will double by 2030 leading to about 8 million slides every year. Third, pathologists can sometimes miss cancers or not correctly report how aggressive the cancer cells are. The Ibex-AI system is designed to find features of cancer on scanned images of biopsy slides. It has shown excellent accuracy in other countries but has not been tested in the NHS. Plan Ibex-AI will be used in real-time on the prostate biopsy tissue slides from 600 men who consent to take part from 6 different NHS hospitals. The Ibex-AI report will be issued without knowledge of the pathologist s report. The pathologist will not be told of the Ibex-AI report. Where the two reports disagree, another three independent pathologists will then review the slides. We will measure how good Ibex-AI is in ruling-out and detecting clinically important prostate cancer. We will measure additional costs of Ibex-AI as well as savings for the NHS, so that we can assess the health economics of introducing Ibex-AI. Patient and Public Involvement Martin Gammon, treated for prostate cancer, will be PPI representative and join the monthly Trial Management Group meeting. We held a patient focus group of men who had been through the diagnostic pathway in the NHS; quick and accurate diagnosis was an important area for them and AI for biopsies was strongly supported. The PPI focus group will advise on the conduct, delivery and dissemination of the study with Martin chairing a meeting of this group in the first 3 months and every 6 months thereafter. In particular, we will ask their guidance on how differences between the first pathology report and expert review, that is triggered by the Ibex-AI software, will be handled and communicated to patients. Dissemination and anticipated outcomes We will present our findings at conferences, publish in high impact journals and share results with trial participants. Findings will be shared with key stakeholders like patient support groups, charities, policy makers and professional medical groups. Traditional and social media will be used to inform patients and the public. We will work with guideline developers so that our findings can inform clinical guidelines early.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS