Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Contact information



Primary contact

Mr Steven Penegar


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

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

NRES Committee North East - Newcastle & North Tyneside 2, 16/07/2014, ref: 14/NE/1062

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Cancer; Subtopic: Bladder Cancer; Disease: Bladder (superficial)


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) [5], 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.

Intervention type



Phase III

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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 life style guidelines

Participant type


Age group




Target number of participants

Planned Sample Size: 533; UK Sample Size: 533

Participant 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 Investigator’s opinion would contraindicate protocol treatment
10. Unable to provide informed consent
11. Unable or unwilling to complete follow up schedule (including questionnaires)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials & Statistics Unit at the Institute of Cancer Research (ICR-CTSU)
Institute of Cancer Research
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Northern Centre for Cancer Care
Freeman Road
High Heaton
Newcastle upon Tyne
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Instititute for Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The main trial results will be published in a peer-reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date


Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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