Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer
| ISRCTN | ISRCTN84013636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84013636 |
| Secondary identifying numbers | 17055 |
- Submission date
- 25/07/2014
- Registration date
- 25/07/2014
- Last edited
- 26/04/2023
- 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
Contact information
Mr Steven Penegar
Scientific
Scientific
Clinical Trials & Statistics Unit at the Institute of Cancer Research (ICR-CTSU)
The Institute of Cancer Research
London
SM2 5NG
United Kingdom
| PHOTO-icrctsu@icr.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | NRES Committee North East - Newcastle & North Tyneside 2, 16/07/2014, ref: 14/NE/1062 |
| Condition | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/09/2014 |
| Overall study end date | 23/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 533; UK Sample Size: 533 |
| Total final enrolment | 538 |
| 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 lifestyle guidelines |
| 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 Investigators 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 | 23/10/2014 |
| Recruitment end date | 14/02/2018 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom
Newcastle upon Tyne
NE7 7DN
United Kingdom
Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
Exeter
EX2 5DW
United Kingdom
Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom
Oxford
OX3 7LE
United Kingdom
Ninewells Hospital and Medical School
Dundee
DD2 1UB
United Kingdom
DD2 1UB
United Kingdom
University College Hospital London
235 Euston Road
London
NW1 2BU
United Kingdom
London
NW1 2BU
United Kingdom
Princess Of Wales Hospital
Coity Road
Bridgend
CF31 1RQ
United Kingdom
Bridgend
CF31 1RQ
United Kingdom
St Peter's Hospital
Guildford Road
Chertsey
KT16 0PZ
United Kingdom
Chertsey
KT16 0PZ
United Kingdom
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
Cottingham
HU16 5JQ
United Kingdom
Basingstoke and North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
James Cook University Hospital
Marton Road
Middlesborough
TS4 3BW
United Kingdom
Middlesborough
TS4 3BW
United Kingdom
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
London
W6 8RF
United Kingdom
Darent Valley Hospital
Darenth Wood Road
Dartford
DA2 8DA
United Kingdom
Dartford
DA2 8DA
United Kingdom
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Southampton
SO16 6YD
United Kingdom
St James’s University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Morriston Hospital
Heol Maes Eglwys
Swansea
SA6 6NL
United Kingdom
Swansea
SA6 6NL
United Kingdom
Royal Stoke University Hospital
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Derby
DE22 3NE
United Kingdom
Barnet General Hospital
Wellhouse Lane
Barnet
EN5 3DJ
United Kingdom
Barnet
EN5 3DJ
United Kingdom
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Stevenage
SG1 4AB
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Northern Centre for Cancer Care
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/09/2019 | 05/10/2020 | Yes | No |
| Results article | 02/09/2022 | 27/09/2022 | Yes | No | |
| Results article | 01/10/2022 | 28/10/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
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
