UK study of AI-based software for prostate cancer detection expands
"We will be looking not only at how well this software performs in a busy clinical setting and whether diagnostic accuracy and efficiency improves, but also assessing the experience of clinicians and patients, and looking at the impact on workflow," says Clare Verrill, BM, FRCPath, MMedEd.
The real-world ARTICULATE PRO study has expanded to include 3 hospital systems across England, all of which are evaluating the impact of the artificial intelligence (AI)-based system Paige Prostate Suite on clinical decision-making in the diagnosis of prostate cancer.1
The FDA authorized the marketing of Paige Prostate in the US in September 2021.
Hospitals now included in the 2-year study are North Bristol Trust Southmead Hospital, University Hospitals Coventry and Warwickshire, and Oxford University Hospitals (OUH) NHS Foundation Trust. According to a news release on the study expansion, each hospital utilizes different digital pathology scanners and information systems and serves a distinct patient population.1
The ARTICULATE PRO trial first launched in March 2023 at the OUH NHS Foundation Trust.2
“The central focus of ARTICULATE PRO is patients. We are striving towards our goal to safely and effectively ensure they benefit the most from powerful AI technology. With the multisite live use of The Paige Prostate Suite, we can systematically study benefits to patients in clinical settings,” said principal investigator Clare Verrill, BM, FRCPath, MMedEd, in a news release on the study.1 Verrill is a cellular pathology consultant and an associate professor of cellular pathology at OUH.
Paige Prostate is designed to provide a supplementary assessment of digitally scanned slide images from prostate biopsies and locate the area with the highest probability of harboring cancer. Pathologists can then examine this specific area further if they did not identify it on their initial assessment.
The FDA authorized the marketing of Paige Prostate in the US in September 2021.3 The authorization was granted following a review of results from a clinical study involving 16 pathologists who assessed 527 slide images of prostate biopsies. All images had been digitized with a scanner. Among the 527 slides assessed in the study, 171 included cancerous tissue and 356 included benign tissue. All pathologists performed 2 assessments of each slide image, one with the assistance of Paige Prostate and one without.
The results showed that detection of cancer on individual slide images was improved by an average of 7.3% with the assistance of Paige Prostate vs the pathologists’ unassisted reads. There was no impact on the assessment of the benign slide images. Of note, the impact of Paige Prostate on final patient diagnosis was not an end point of the study, as that is typically determined following multiple biopsies.
The ARTICULATE PRO study, however, will assess impact of Paige Prostate Suite on the clinical decision-making, service delivery, and use of resources among pathologists utilizing the software. The trial is being funded by the Artificial Intelligence in Health and Care Award from the Accelerated Access Collaborative.
“One of our key aims in the health service is to diagnose cancers accurately and at an earlier stage so that treatment can be delivered more quickly and, ultimately, outcomes for patients improve. If we can harness this diagnostic technology to achieve this, it will be great news for patients,” added Verrill in the news release of the initial study launch.2 “That’s why this evaluation––one of the first of its kind––is an important step. We will be looking not only at how well this software performs in a busy clinical setting and whether diagnostic accuracy and efficiency improves, but also assessing the experience of clinicians and patients, and looking at the impact on workflow.”
References
1. Three UK-based hospital systems exploring the power of Paige’s AI for diagnosing prostate cancer in live clinical settings. News release. Published online and accessed July 22, 2024. https://www.businesswire.com/news/home/20240722858117/en/Three-UK-Based-Hospital-Systems-Exploring-the-Power-of-Paige%E2%80%99s-AI-for-Diagnosing-Prostate-Cancer-in-Live-Clinical-Settings
2. Prostate cancer AI diagnosis tool begins evaluation in Oxford. News release. March 10, 2023. Accessed July 22, 2024. https://paige.ai/prostate-cancer-ai-diagnosis-tool-begins-evaluation-in-oxford/
3. FDA authorizes software that can help identify prostate cancer. News release. US Food & Drug Administration. September 21, 2021. Accessed July 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-software-can-help-identify-prostate-cancer
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