Bladder cancer Cancer Malignant neoplasm of bladder
Conditions
Interventions
There are three overlapping stages:
1. Feasibility stage: the anticipated duration is 1 year in three centres
150 patients
2. Intermediate stage: the estimated sample size for this stage is event-driven and requires at least 20 MIBC patients to have definitive treatment across both treatment arms
3. Final cl
or approximately 950 patients with bladder cancer) - updated 26/07/2022: NOT DONE (recruitment closed after the Feasibility/Intermediate stages)
Patients are randomly assigned to either the standard
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. =18 years of age 3. Patients attending haematuria clinic for the investigation of symptoms suspicious of bladder cancer (initial consent process) 4. Patients given a diagnosis of suspected bladder cancer and requiring a TURBT based on visual cystoscopic examination of the bladder (confirmatory consent process, post cystoscopy) Note: as the study does not involve additional drug therapy or ionising radiation, there are no restrictions on women of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Patients unable or unwilling to undergo MRI. Criteria include but is not exclusive of the presence of foreign bodies or pacemakers, claustrophobia, adverse reactions to MRI contrast media and eGFR of less than 40 ml/min/1.73m2 2. Patients who are pregnant or breastfeeding 3. Previous diagnosis of bladder cancer 4. Previous entry into the present trial 5. Patients not suitable/fit for radical treatment Note: The study does not include upper age related exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility stage: the proportion of possible MIBC patients randomised to pathway 2 who correctly follow the pathway protocol, measured after 150 patients have been entered into the study and completed pathway 2 2. Intermediate stage: the time to definitive treatment (TTDT) for all possible MIBC patients 3. Final clinical stage: clinical progression-free survival (CPFS), assessed after 2 years follow-up - updated 26/07/2022: NOT DONE (recruitment closed after the Feasibility/Intermediate stages) | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility stage: Measured after 150 patients have been entered into the study and completed pathway 2: 1. Overall proportion of patients who correctly follow protocol 2. Recruitment and retention rates at each study site 3. Counts of each definitive treatment Intermediate stage: 1. TTDT for all patients 2. TTDT for probable NMIBC patients 3. Proportion of all patients who correctly follow pathway protocol 4. Recruitment and retention rates at each study site Final clinical stage - updated 26/07/2022: NOT DONE (recruitment closed after the Feasibility/Intermediate stages): 1. Cost-effectiveness of each pathway; for the health economics analysis questionnaire EQ-5DL is completed at baseline, 3, 6, 9, 12, 18 and 24 months 2. Quality of life, measured using the EORTC-QLQ-BLM30 questionnaire at baseline, 3, 6, 9, 12, 18 and 24 months Assessed at 2 years follow-up: 3. The proportion of patients who correctly follow pathway protocol 4. TTDT for all possible MIBC patients 5. TTDT for all probable NMIBC patients 6. TTDT for all MIBC patients 7. TTDT for all NMIBC patients 8. Time to correct treatment 9. Time to each treatment type 10. Time to recurrence, progression or metastatic disease 11. Number of recurrences; progressions and incidence of metastatic disease 12. Number of each type of treatment(s) received 13. Accuracy of MRI/TURBT by comparison with histological confirmed diagnoses 14. Overall and disease specific survival 15. Number of unnecessary radical cystectomies 16. Number of SAEs | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactAna Hughes
Outcome results
None listed