Please enable JavaScript or talk to your local administrator to get JavaScript enabled.

Project

PHOTOdynamic versus white light-guided treatment of non-muscle invasive bladder cancer: A randomised trial of clinical and cost-effectiveness (The PHOTO Trial)

Funder: NIHR Evaluation Trials and Studies Coordinating Centre

Funding period
GBP 2.4 M
USD 3.9 M
Funding amount
Abstract
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. Study design: Potential participants for the trial will be identified at rapid access clinics for people with blood in their urine (haematuria). Usual assessment includes cystoscopy under local anaesthetic and if there is bladder tumour seen then the patient has surgery under a general anaesthetic at a later date. For patients with a new diagnosis of intermediate or high risk NMIBC who agree to join our study, we will randomly allocate treatment to photodynamic or standard white light surgery to test if there is a difference in recurrence rate at three years. Patients will be recruited following informed consent to participate using processes approved by an NHS Research Ethics Committee. Apart from treatment allocation and measurement of study outcomes, participants will have standard NHS follow up. Based on statistical calculations, we aim to recruit 533 participants over two and half years who will be followed up for at least three years across 30 UK hospitals. Outcomes: The main clinical outcome will be the difference in the rates of recurrence between the two study groups at three years. We will also measure the rate of disease progression and changes to participants’ health related quality of life (well being) over the three years. The effect on the quality of life will be particularly important and we will assess this using a specifically designed questionnaire. In addition, we will examine the safety of PDD resection compared with the standard approach. To assess any longer term benefits of photodynamic diagnosis we will use a mathematical model to give a prediction of progression rates, quality of life and freedom from cancer over each participant’s lifetime. We will use the measurements we collect and the model to work out whether use of photodynamic diagnosis is worthwhile to the NHS in terms of balancing any benefit to people’s health against the added costs (cost-effectiveness). Finally we will explore the impact of urologists having to learn the new technique by comparing patient outcomes after surgery by surgeons who are experienced and those who less experienced in the use of photodynamic diagnosis (all surgeons will be experienced at cystoscopic resection). The results of this study will enable patients, clinicians and policy-makers to decide the worth of photodynamic surgery as part of treatment of bladder cancer.
Similar projects All >
Sorted by: Start Date
Project list item
Intravesical delivery of an Fc-enhanced CD40 agonist antibody for the treatment of bladder cancer

Bladder Cancer Advocacy Network to Jeffrey Ravetch, David Knorr

USD 300,000
2020 - 2022
Project list item
Epigenetic regulators of subtype plasticity in bladder cancer

Bladder Cancer Advocacy Network to John Robert Christin

USD 1,700
2020 - 2020
Project list item
Recombinant CCL2 as a novel treatment strategy for bladder cancer

Bladder Cancer Advocacy Network to Neelam Mukherjee, Robert Scott Svatek

USD 50,000
2020 - 2021
Project list item
Defining NRF2 induced tumor invasion in bladder cancer

Bladder Cancer Advocacy Network to Yuki Kita, William Youngkwan Kim, Bernard Weissman

USD 50,000
2020 - 2021
Project list item
Alpha1H: A Unique Bladder Cancer Therapeutic, Acting with Great Precision

European Commission

USD 2,452,885
2020 - 2022

System

Categories
  • FOR (ANZSRC)

    1103 Clinical Sciences

  • FOR (ANZSRC)

    1112 Oncology and Carcinogenesis

  • FOR (ANZSRC)

    1117 Public Health and Health Services

  • RCDC

    Cancer

  • RCDC

    Clinical Research

  • RCDC

    Clinical Trials and Supportive Activities

  • RCDC

    Comparative Effectiveness Research

  • RCDC

    Rare Diseases

  • RCDC

    Urologic Diseases

  • HRCS HC

    Cancer

  • HRCS RAC

    6.4 Surgery

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science