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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Margaret Horton
+44 (0)7408852075
margaret.horton@paige.ai


Prof Clare Verrill
+44 (0)1865 2 20150
Clare.Verrill@ouh.nhs.uk


Ms Monica Dolton
+44 (0)1865 612273
monica.dolton@nds.ox.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Examining the impacts of pathologists using the assistance of computer technology (artificial intelligence software) on the diagnosis of prostate cancer biopsies
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Examining the impacts of pathologists using the assistance of computer technology (artificial intelligence software) on the diagnosis of prostate cancer biopsies

Not Recruiting

Open to: Male

Age: Adult

Bristol Oxford Coventry

Medical Conditions

Prostate cancer

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Prostate cancer is currently diagnosed by histopathologists who expertly examine thin slices of tissue that are prepared as glass slides and viewed under a microscope. The pathologists assess whether cancer is present, how aggressive it is, and how much is present so that treatment decisions can be taken for patients. However, there are increasing volumes of cases and cases are becoming more complex; there is also a shortage of specialised pathologists that is especially felt in the UK and Europe. By using digital images and with the assistance of artificial intelligence (AI)-based software, pathologists can do routine screening, grading and measuring with assistance to enable a safe and more efficient service. Paige Prostate is a software device that has regulatory approval for clinical use and is the first-ever AI-based software to receive FDA approval in pathology. The aim of this study is to use the Paige Prostate cancer detection and quantification and grading software to assist prostate biopsy reporting for patients across three hospitals in England (UK) and compare the performance of pathologists either using or not using Paige Prostate.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

28 Apr 2022 29 Feb 2024

Publications

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35626380/ (added 01/07/2022)

This is a histopathologist-led study conceived with patient representatives that is conducted at hospital pathology laboratories in a real clinical setting as part of the standard practice for diagnosing prostate cancer. This study examines if and how pathologists’ diagnoses are changed when they see and use the information made available by Paige Prostate. The outputs of Paige Prostate include visual overlays that draw the attention of pathologists to areas of prostate biopsy tissue that are suspicious for harbouring cancer. Paige Prostate also displays the grade, length and quantity of tumour as numerical outputs. Pathologists will be able to see and view the outputs of Paige Prostate before signing out cases and reporting results to patients. If pathologists have changed their original diagnoses due to using Paige Prostate, then these discrepancies will be examined further with additional tests and additional review before final case authorisation. The impact of these discrepancies on patient treatment scenarios as well as costs to the health system will be modelled to assess if and how Paige Prostate can improve the efficiency and quality of prostate biopsy diagnosis. The clinician experience will also be surveyed and resource efficiency measured by studying the impact of routine use of Paige Prostate compared to current resources used. This study will also create guidelines and standards for best practice to safely introduce AI assistance into pathology diagnosis, both professional guidelines as well as patient-led guidelines from patient and public representatives.


Patients undergoing prostate biopsy as part of the standard diagnostic pathway at the participating hospitals

You can take part if:



You may not be able to take part if:


1. Patients who have opted out of clinical care via the existing 'consent to examination or treatment policy'2. Non-prostate biopsy tissue


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southmead Hospital
    Southmead Road Westbury-on-Trym
    Bristol
    BS10 5NB
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • University Hospital Coventry
    Clifford Bridge Road
    Coventry
    CV2 2DX

Paige Prostate is not a replacement for the pathologist but rather provides additional information to help pathologists. Pathologists determine and authorise the diagnosis of all cases and can agree or disagree with the findings of Paige Prostate. This is a guiding principle of the study and was formed together with patient representatives and the clinical study team. There are no risks to patients in this study as they receive their full current standard of care with the addition of a market-authorised and clinically validated system in the hands of experts taking all decisions.

Ms Monica Dolton
+44 (0)1865 612273
monica.dolton@nds.ox.ac.uk


Prof Clare Verrill
+44 (0)1865 2 20150
Clare.Verrill@ouh.nhs.uk


Dr Margaret Horton
+44 (0)7408852075
margaret.horton@paige.ai



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Oxford and funded by Accelerated Access Collaborative, NHSx, Artificial Intelligence in Health & Care Award.



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Read full details for Trial ID: ISRCTN91685765
Last updated 31 August 2023

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