{
  "abstract": "Introduction Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.Methods and analysis The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.Ethics and dissemination The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.Trial registration number NCT06714630.",
  "authors": [
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK",
        "Institute for Imaging, Data and Communications, The University of Edinburgh School of Engineering, Edinburgh, UK",
        "Oncology Physics, Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "William H Nailon"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK",
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "David J Noble"
    },
    {
      "affiliations": [
        "Usher Institute, University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK"
      ],
      "name": "Ewen Harrison"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK"
      ],
      "name": "Zhuolin Yang"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK",
        "Usher Institute, University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK"
      ],
      "name": "Sarah Elliot"
    },
    {
      "affiliations": [
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Archie MacNair"
    },
    {
      "affiliations": [
        "UoE, Baynes Centre, Edinburgh Parallel Computing Centre, Edinburgh, UK"
      ],
      "name": "George Beckett"
    },
    {
      "affiliations": [
        "UoE, Baynes Centre, Edinburgh Parallel Computing Centre, Edinburgh, UK"
      ],
      "name": "Antony Hallam"
    },
    {
      "affiliations": [
        "Division of Community Health Sciences, University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK"
      ],
      "name": "Aziz Sheikh"
    },
    {
      "affiliations": [
        "Usher Institute, University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK"
      ],
      "name": "Nicholas Mills"
    },
    {
      "affiliations": [
        "Research Data Scotland, Baynes Centre, University of Edinburgh Institute of Governance, Edinburgh, UK"
      ],
      "name": "Roger Halliday"
    },
    {
      "affiliations": [
        "Scottish Cancer Registry, Public Health Scotland, Edinburgh, UK",
        "Public Health Medicine, University of Glasgow, Glasgow, UK"
      ],
      "name": "David Morrison"
    },
    {
      "affiliations": [
        "Institute of Cancer Sciences, University of Glasgow, Glasgow, UK",
        "Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, Glasgow, UK"
      ],
      "name": "Anthony Chalmers"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK"
      ],
      "name": "David Cameron"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK",
        "Medical Oncology, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Charlie Gourley"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK"
      ],
      "name": "Peter Hall"
    },
    {
      "affiliations": [
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Christina Lilley"
    },
    {
      "affiliations": [
        "Oncology Physics, Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Linda J Carruthers"
    },
    {
      "affiliations": [
        "Radiotherapy Physics, Newcastle Upon Tyne Hospitals NHS Foundation Trust Cancer Services, Newcastle upon Tyne, UK"
      ],
      "name": "Michael Trainer"
    },
    {
      "affiliations": [
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Donna Burns"
    },
    {
      "affiliations": [
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Fiona Dee"
    },
    {
      "affiliations": [
        "Radiotherapy Physics, NHS Tayside, Dundee, UK"
      ],
      "name": "Sankar Andiappa"
    },
    {
      "affiliations": [
        "Radiotherapy Physics, NHS Tayside, Dundee, UK"
      ],
      "name": "Adrian Lonsdale"
    },
    {
      "affiliations": [
        "Radiotherapy Physics, NHS Tayside, Dundee, UK"
      ],
      "name": "Megan Couper"
    },
    {
      "affiliations": [
        "Radiotherapy, NHS Tayside, Dundee, UK"
      ],
      "name": "Kirsty Farnan"
    },
    {
      "affiliations": [
        "Radiotherapy Physics, NHS Grampian, Aberdeen, UK"
      ],
      "name": "John McLellan"
    },
    {
      "affiliations": [
        "Radiotherapy Physics, NHS Grampian, Aberdeen, UK"
      ],
      "name": "Andrew Miller"
    },
    {
      "affiliations": [
        "Radiotherapy, NHS Grampian, Aberdeen, UK"
      ],
      "name": "Jacqueline Ogg"
    },
    {
      "affiliations": [
        "Radiotherapy, NHS Grampian, Aberdeen, UK"
      ],
      "name": "Jillian Moses"
    },
    {
      "affiliations": [
        "Radiotherapy Physics, NHS Highland, Inverness, UK"
      ],
      "name": "Steve Colligan"
    },
    {
      "affiliations": [
        "Clinical Oncology, NHS Grampian, Aberdeen, UK"
      ],
      "name": "Graham MacDonald"
    },
    {
      "affiliations": [
        "Clinical Oncology, NHS Highland, Inverness, UK"
      ],
      "name": "Neil McPhail"
    },
    {
      "affiliations": [
        "Clinical Oncology, NHS Tayside, Dundee, UK"
      ],
      "name": "Paddy Niblock"
    },
    {
      "affiliations": [
        "Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, Glasgow, UK"
      ],
      "name": "Nicholas MacLeod"
    },
    {
      "affiliations": [
        "Institute for Imaging, Data and Communications, The University of Edinburgh School of Engineering, Edinburgh, UK"
      ],
      "name": "Mike E Davies"
    },
    {
      "affiliations": [
        "Institute for Imaging, Data and Communications, The University of Edinburgh School of Engineering, Edinburgh, UK"
      ],
      "name": "Dave I Laurenson"
    },
    {
      "affiliations": [
        "Institute for Imaging, Data and Communications, The University of Edinburgh School of Engineering, Edinburgh, UK"
      ],
      "name": "James R Hopgood"
    },
    {
      "affiliations": [
        "South East Scottish Cancer Research Network (SESCRN), NHS Lothian, Edinburgh, Edinburgh, UK"
      ],
      "name": "Dorothy Boyle"
    },
    {
      "affiliations": [
        "Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, Glasgow, UK"
      ],
      "name": "Claire Paterson"
    },
    {
      "affiliations": [
        "Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, Glasgow, UK"
      ],
      "name": "Derek Grose"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK",
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Iain Phillips"
    },
    {
      "affiliations": [
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Stephen Harrow"
    },
    {
      "affiliations": [
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK",
        "Radiation Oncology, Centre Hospitalier Lyon Sud, Pierre-Bénite, Auvergne-Rhône-Alpes, France"
      ],
      "name": "Thomas Berger"
    },
    {
      "affiliations": [
        "Oncology Physics, Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Leila E A Shelley"
    },
    {
      "affiliations": [
        "Clinical Oncology, NHS Tayside, Dundee, UK"
      ],
      "name": "Ian Sanders"
    },
    {
      "affiliations": [
        "Medical Physics, NHS Tayside, Dundee, UK"
      ],
      "name": "Shelley Henderson"
    },
    {
      "affiliations": [
        "Beatson West of Scotland Cancer Centre, NHS Greater Glasgow and Clyde, Glasgow, UK"
      ],
      "name": "Aileen Duffton"
    },
    {
      "affiliations": [
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Joanne Mitchell"
    },
    {
      "affiliations": [
        "Beatson West of Scotland Cancer Centre, NHS Greater Glasgow and Clyde, Glasgow, UK"
      ],
      "name": "Alasdair Rutherford"
    },
    {
      "affiliations": [
        "Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, Lothian, UK",
        "Edinburgh Cancer Centre, NHS Lothian, Edinburgh, UK"
      ],
      "name": "Duncan B McLaren"
    }
  ],
  "title": "Protocol for the PROSECCA study: a new approach for predicting radiotherapy outcome using artificial intelligence and electronic population-based healthcare data",
  "uid": "184e592c-258c-579a-b9ee-96e3d9cd4e6d"
}