Abstract
Introduction Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective. Methods and analysis PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients' lifetime. Ethics and dissemination Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature. Trial registration number ISRCTN84013636.
| Original language | English |
|---|---|
| Article number | e22268 |
| Number of pages | 9 |
| Journal | BMJ Open |
| Volume | 9 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 3 Sept 2019 |
Bibliographical note
Funding This project was funded by the National Institute for Health Research HTA(project number 11/142/02). The PHOTO trial is sponsored by Newcastle upon Tyne Hospitals National Health Service Foundation Trust.
Funding
1Urology, Northern Institute for Cancer Research, Newcastle upon Tyne, UK 2Urology and Head and Neck Trials Team, Institute of Cancer Research, London, UK 3Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK 4Urology and Head and Neck Trials Team, Institute of Cancer Research, London, UK 5Health Economics Group, Institute of Health and Society, Newcastle University, Newcastle, UK 6Health Economics Group, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK 7Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK 8Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK 9Department of Surgery, University of Aberdeen, Aberdeen, UK 10Health Service Research Unit, University of Aberdeen, Aberdeen, UK 11Urology, Hampshire Hospitals NHS Foundation Trust, Winchester, UK 12Department of Urology, Western General Hospital, Edinburgh, UK 13Department of Medicine, University of Dundee, Dundee, UK 14Urology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK 15Urology, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK 16Department of Urology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK 17Trial Management Group, PHOTO Trial, UK 18Urology, Northern Institute for Cancer Research, Newcastle upon Tyne, UK 19Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK 20Urology and Head and Neck Trials Team, The Institute of Cancer Research, London, UK Contributors ZT and RH: conception and design of the work, drafting of the article, critical revision of the article and final approval of the version to be published. RL, AD and AM: conception and design of the work, data collection, drafting of the article, critical revision of the article and final approval of the version to be published. LV, JN and EH: conception and design of the work, critical revision of the article and final approval of the version to be published. SP: data collection, critical revision of the article and final approval of the version to be published. JS and GM: design of the work, critical revision of the article and final approval of the version to be published. PHOTO TMG members: trial management, data collection and final approval of the version to be published. Members of this group include: JDK, RP, JND, CR, HM, PM, GN, JC, HL, JM, ET and EC. Funding This project was funded by the National Institute for Health Research HTA (project number 11/142/02). The PHOTO trial is sponsored by Newcastle upon Tyne Hospitals National Health Service Foundation Trust.
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Keywords
- bladder cancer
- cost effectiveness
- health economics
- photodynamic diagnosis
- quality of life
- sample biorepository
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