Photodynamic Versus White Light-Guided Treatment of Non-Muscle Invasive Bladder Cancer: A Study Protocol for a Randomised Trial of Clinical and Cost-Effectiveness

Follow-up of non-muscle invasive bladder cancer (NMIBC) patients is difficult. Cystoscopic surveillance for a history of bladder cancer can be required up to four times/year which leads to bladder cancer having one of the highest lifetime treatment costs per patient and is associated with a considerable burden for those affected. Initial surgical treatment is by a transurethral resection of bladder tumour (TURBT) with the goal of preventing recurrence and progression to higher stage, life threatening, muscle invasive disease. Although BCG and mitomycin washes in the bladder following surgery help, active research into reducing recurrence through better resection in the first instance, such as photodynamic guided resection (the PHOTO trial), described in our recent BMJ Open protocol publication is essential.¹

PHOTO is run by a collaboration between Newcastle University Centre for Cancer (NUCancer), The Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen and the Clinical Trials and Statistics Unit at The Institute of Cancer Research, London (ICR-CTSU). Target recruitment is now complete with 533 patients randomised by 22 NHS sites (one of the largest trials recruiting in this disease area). Patients will continue to be followed-up according to standard practice to investigate both clinical effectiveness (comparison of time to recurrence, with a principal point of interest at three years) and cost-effectiveness (evaluation of incremental cost for recurrence avoided and cost-utility as the incremental cost per quality-adjusted life year (QALY) gained at three years). Primary results are expected to be published in 2020/2021.

In addition to main trial outcomes, a comprehensive, prospective trial associated bladder cancer biorepository of serially collected samples (blood, urine, and FFPE cores) from consenting PHOTO participants has been established (Newcastle University Centre for Cancer, UK). This valuable resource is being used in complementary translational research, to validate prognostic and predictive biomarkers which have shown promising clinical value in potentially replacing second resection and/or to safely reduce the burden of cystoscopy during surveillance (identified as a priority area of clinical need in an NIHR HTA evidence synthesis, HTA 07/02/01).

This abstract is independent research funded by the National Institute for Health Research (Health Technology Assessment, 11/142/02 - PHOTOdynamic versus white light-guided treatment of non-muscle invasive bladder cancer: A randomised trial of clinical and cost-effectiveness (The PHOTO Trial)). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

Written by: Emma Clark, PhD, BSc, Translational Research Associate, NU Cancer, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University

1. Tandogdu, Zafer, Rebecca Lewis, Anne Duncan, Steven Penegar, Alison McDonald, Luke Vale, Jing Shen et al. "Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness." BMJ open 9, no. 9 (2019): e022268.

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