Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer

ISRCTN	ISRCTN84013636
DOI	https://doi.org/10.1186/ISRCTN84013636
Protocol serial number	17055
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder	National Institute for Health Research

Submission date: 25/07/2014
Registration date: 25/07/2014
Last edited: 27/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-white-light-blue-light-surgery-people-bladder-cancer-photo

Contact information

Mr Steven Penegar
Scientific

Clinical Trials & Statistics Unit at the Institute of Cancer Research (ICR-CTSU)
The Institute of Cancer Research
London
SM2 5NG
United Kingdom

Email	PHOTO-icrctsu@icr.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	PHOTOdynamic versus white light-guided treatment of non-muscle invasive bladder cancer: randomised trial of clinical and cost-effectiveness
Study acronym	PHOTO
Study objectives	Bladder cancer is a high priority area for research into clinical and cost-effective management and the findings from the PHOTO trial are likely to remain highly relevant and important to the needs of the NHS over the next 20 years, the expected life span of the equipment for the PDD technology. A further compelling reason for the study is the current piecemeal adoption of PDD within the NHS, resulting in variation in provision of PDD service. This gives further urgent need for better quality evidence to guide providers of bladder cancer services and the relevant practice guidance authorities to make early decisions around wholesale adoption or disinvestment in PDD technology.
Ethics approval(s)	NRES Committee North East - Newcastle & North Tyneside 2, 16/07/2014, ref: 14/NE/1062
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Bladder Cancer; Disease: Bladder (superficial)
Intervention	Randomisation will be undertaken centrally using either the secure web-based or the 24-hour Interactive Voice Response randomisation system at the Centre for Healthcare Randomised Trials (CHaRT) in Aberdeen, using minimisation by centre and gender, to allocate participants 1:1 to the control and experimental groups. The minimisation algorithm will incorporate a random element in order to prevent deterministic treatment allocation. Guidance on treatment and follow up of NMIBC, developed by the European Association of Urology (EAU), recommend that patients who have high risk disease, or where there are indications that the TURT may not have been complete, should have a further resection of the original disease site 26 weeks after initial treatment. This reresection is intended to ensure that the initial resection was as complete as possible and to check that muscle invasive disease, which would require further radical treatment, has not been missed. Following initial or reresection, patients in both intermediate and high risk groups are recommended to receive further (adjuvant) intravesical treatment with the aim of reducing the risk of future recurrence and progression. Patients in the intermediate risk group are usually given further treatment with chemotherapy once a week for 6 weeks. Patients in the high risk group are treated with intravesical immunotherapy weekly for 6 weeks and may have further treatments every few months for up to 3 years. Patients will have 3 monthly cystoscopies to check for any sign of recurrence for 2 years, then 6 monthly to five years, after which they will continue to be followed up annually. PHOTO follow-up schedule All participants will be followed up according to EAU guidelines, with regular cystoscopies initially 3 monthly following surgery (either initial TURT or second TURT for those who have one). The PHOTO trial will collect the following information at the 3,6,9,12,18,24 and 36 month routine visits: 1. Outcome of cystoscopy 2. Adverse event information Participants will be asked to complete quality of life and health service utilisation questionnaires 3, 6, 12, 18, 24 and 36 months post randomisation. Participants will also be asked to complete a patient costs questionnaire 30 months after randomisation. Questionnaires will be posted to patients' homes by CHaRT. Added 27/11/2025: Additional Data Linkage Information: Participants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact.
Intervention type	Other
Primary outcome measure(s)	1. To compare time to recurrence, for each of the two treatment strategies, with a principal point of interest at 3 years. 2. To evaluate cost effectiveness by the incremental cost for recurrence avoided and cost utility as the incremental cost per quality adjusted life year (QALY) gained at three years.
Key secondary outcome measure(s)	Secondary objectives will further explore clinical and cost effectiveness of photo dynamic surgery: Clinical effectiveness: 1. Measure relative rate of disease progression at 3 years 2. Measure relative harms and safety 3. Measure health-related quality of life (HRQoL) and cancer specific survival
Completion date	23/06/2021

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	16 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	533
Total final enrolment	538
Key inclusion criteria	1. Adult men and women aged ≥ 16 years 2. First suspected diagnosis of bladder cancer 3. Visual/ultrasound/CT diagnosis of intermediate/high risk NMIBC 3.1. White light visual appearances of intermediate or high risk disease (=> 3cm, two or more tumours, or flat velvety erythematous changes alerting a clinical suspicion of CIS). 3.2. Suspicion of papillary bladder tumour > 3cm based on ultrasound or computerized tomography (CT) scanning (without hydronephrosis) 4. Written informed consent for participation prior to any study specific procedures 5. Willing to comply with lifestyle guidelines
Key exclusion criteria	1. Visual evidence of low risk NMIBC (solitary tumour < 3cm) 2. Visual evidence of MIBC on preliminary cystoscopy, i.e. nonpapillary or sessile mass (attached directly by its base without a stalk) 3. Imaging evidence of MIBC CT/USS (this includes the presence of hydronephrosis, which may be present despite clear imaging of MIBC in the bladder) 4. Upper tract (kidney or ureteric) tumours on imaging 5. Any other malignancy in the past 2 years (except: nonmelanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, DCIS/LCIS of the breast or prostate cancer in patients who have a life expectancy of >5 years upon trial entry) 6. Evidence of metastases 7. Porphyria or known hypersensitivity to porphyrins 8. Known pregnancy (based on history and without formal testing, in keeping with day-to-day NHS practice of PDD use) 9. Any other conditions that in the Principal Investigators opinion would contraindicate protocol treatment 10. Unable to provide informed consent 11. Unable or unwilling to complete follow up schedule (including questionnaires)
Date of first enrolment	23/10/2014
Date of final enrolment	14/02/2018

Locations

Countries of recruitment

United Kingdom
England
Scotland
Wales

Study participating centres

Freeman Hospital

Freeman Road
Newcastle upon Tyne
NE7 7DN
England

Royal Devon and Exeter Hospital

Barrack Road
Exeter
EX2 5DW
England

Churchill Hospital

Old Road
Oxford
OX3 7LE
England

Ninewells Hospital and Medical School

-
Dundee
DD2 1UB
Scotland

University College Hospital London

235 Euston Road
London
NW1 2BU
England

Princess Of Wales Hospital

Coity Road
Bridgend
CF31 1RQ
Wales

St Peter's Hospital

Guildford Road
Chertsey
KT16 0PZ
England

Western General Hospital

Crewe Road South
Edinburgh
EH4 2XU
Scotland

Castle Hill Hospital

Castle Road
Cottingham
HU16 5JQ
England

Basingstoke and North Hampshire Hospital

Aldermaston Road
Basingstoke
RG24 9NA
England

James Cook University Hospital

Marton Road
Middlesborough
TS4 3BW
England

Charing Cross Hospital

Fulham Palace Road
London
W6 8RF
England

Darent Valley Hospital

Darenth Wood Road
Dartford
DA2 8DA
England

Southampton General Hospital

Tremona Road
Southampton
SO16 6YD
England

St James’s University Hospital

Beckett Street
Leeds
LS9 7TF
England

Morriston Hospital

Heol Maes Eglwys
Swansea
SA6 6NL
Wales

Royal Stoke University Hospital

Newcastle Road
Stoke-on-Trent
ST4 6QG
England

Salisbury District Hospital

Odstock Road
Salisbury
SP2 8BJ
England

Aberdeen Royal Infirmary

Foresterhill
Aberdeen
AB25 2ZN
Scotland

Royal Derby Hospital

Uttoxeter Road
Derby
DE22 3NE
England

Barnet General Hospital

Wellhouse Lane
Barnet
EN5 3DJ
England

Lister Hospital

Coreys Mill Lane
Stevenage
SG1 4AB
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		02/09/2022	27/09/2022	Yes	No
Results article		01/10/2022	28/10/2022	Yes	No
Protocol article	protocol	03/09/2019	05/10/2020	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/11/2025: The interventions were updated.
26/04/2023: Cancer Research UK plain English summary link updated in the plain English summary field.
28/10/2022: Publication reference added.
27/09/2022: Publication reference added.
16/03/2022: The following changes have been made:
1. The overall trial end date has been changed from 01/09/2020 to 23/06/2021 and the plain English summary has been updated to reflect this change.
2. The total final enrolment number has been added.
3. The intention to publish date has been changed from 30/09/2021 to 30/09/2022.
05/10/2020: Publication reference added.
16/02/2018: The recruitment end date was changed from 31/01/2018 to 14/02/2018.
17/01/2018: The recruitment end date was changed from 31/12/2017 to 31/01/2018.
19/12/2016: The overall trial end date has been updated from 28/02/2017 to 01/09/2020 and the recruitment dates have been updated from 01/09/2014 - 28/02/2017 to 23/10/2014 - 31/12/2017. In addition, the publication and dissemination plan and IPD sharing plan have been added.
12/10/2016: Changed study contact details