The PHOTO Trial

• Research type

  Research Study

• Full title

  PHOTOdynamic versus white light-guided treatment of non-muscle invasive bladder cancer: randomised trial of clinical and cost-effectiveness

• IRAS ID

  140391

• Contact name

  Rakesh Heer

• Contact email

  Rakesh.Heer@ncl.ac.uk

• Sponsor organisation

  The Newcastle upon Tyne Hospitals NHS Foundation Trust

• Clinicaltrials.gov Identifier

  ICR-CTSU/2014/10045, ICR-CTSU protocol number

• Research summary

  Aim: To determine whether blue light (photodynamic) surgery is better than conventional surgery in the treatment of bladder cancer and whether its use is worthwhile for the NHS.
  Background: Bladder cancer is a common disease in the UK, with over 10,500 cases diagnosed each year. The most common form of bladder cancer (8 out of 10 cases) involves the lining of the bladder – this is termed non-muscle invasive bladder cancer (NMIBC). These tumours can be removed in an operation using a telescopic instrument (cystoscope) passed through the urethra into the bladder. Unfortunately NMIBC frequently comes back (recurs) after initial treatment and patients require regular cystoscopies and surgeries. As a consequence, bladder cancer has one of the highest lifetime treatment costs per patient and can be a considerable burden for those affected. In some instances the recurrent tumour can be worse than the first, progressing to become life threatening and requiring treatment with surgery or radiotherapy.
  It is estimated that one in three patients who suffer a recurrence had disease that was not visible or had been overlooked during the original surgery under standard white light. Photodynamic surgery using a blue light is a treatment that could result in long term reduction of recurrence and progression of NMIBC for patients. Following the introduction of a light-sensitive solution into the bladder, blue light causes tumours to fluoresce, making identification and complete resection easier. A recent review of current evidence suggested surgery guided by photodynamic diagnosis in the short term offered better outcomes for patients who had intermediate or high risk of recurrence. However, the longer-term value of photodynamic-guided surgery in reducing recurrence and progression requires further evaluation and forms the focus of our study.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  14/NE/1062

• Date of REC Opinion

  25 Jul 2014

• REC opinion

  Favourable Opinion