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

Phase 3

Completed

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

Registration Number: ISRCTN84013636

Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary: 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31481549/ protocol (added 05/10/2020) 2022 Results article in https://doi.org/10.1056/EVIDoa2200092 (added 27/09/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36300825/ (added 28/10/2022)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 538

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To compare time to recurrence, for each of the two treatment strategies, with a principal point of interest at 3 years.<br>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

Name	Time	Method
Secondary objectives will further explore clinical and cost effectiveness of photo dynamic surgery:<br>Clinical effectiveness:<br>1. Measure relative rate of disease progression at 3 years<br>2. Measure relative harms and safety<br>3. Measure health-related quality of life (HRQoL) and cancer specific survival