CHAIROS study

A study to assess the clinical and cost-effectiveness of the Galen Prostate Artificial Intelligence Histology system in diagnosing clinically important prostate cancer on prostate biopsy tissue slides

Prostate biopsy tissue is processed in the laboratory and cut into smaller sections and placed on small glass slides for the pathology doctor to look at under a microscope. The purpose of the CHAIROS study is to carry out a very detailed testing of how well a new artificial intelligence (AI) software is in ruling-out and detecting prostate cancer on high resolution images taken of prostate biopsy tissue.

The study is divided into two stages. The first is the Calibration Stage. This is where patients who have already had prostate biopsies will be approached as part of their normal care in the past 48 months, to allow the study team to take high-resolution scans of their biopsy tissue slides. These high-resolution images will be looked at by a pathologist who will draw out where all the different types of tissue are such as cancer, atrophy, inflammation, and high-grade PIN in addition to any other features. These will then be used to fine-tune the AI software ahead of the Validation Stage.

The Validation Stage will test how accurate the AI software is in 600 patients. Patients who are advised and agreed to have a prostate biopsy will be asked to consider participating. If they agree, and after the biopsies have been taken and processed by the NHS laboratory to create slides, the study team will take high resolution images of these slides. The AI software will evaluate these slides independently of the pathology doctor and vice versa.  Independent pathologists will also be asked to also look at the slides. The AI software will be compared to the pathology doctors' reports.

If the AI software is shown to be accurate, then the AI software might be used in the NHS in the future, to help pathology doctors and patients.