Transurethral resection of bladder tumour (TURBT) has been the mainstay of bladder cancer staging for a century. The objective of the trial was to assess the feasibility and efficacy of the substitution of TURBT with MRI and biopsy in the staging of patients with suspected muscle invasive bladder cancer (MIBC). The hypothesis being tested was that image directed staging would shorten time to correct treatment for MIBC patients.
Patients with suspected bladder cancer were identified via the haematuria clinic. Those with possible muscle invasive disease (assessed on a Likert scale at flexible cystoscopy) were randomised to standard TURBT assessment (Pathway 1) or MRI based assessment (Pathway 2) with tumour biopsy. Patients with probable non-muscle invasive disease (NMIBC) all underwent TURBT. Primary outcome for Feasibility Phase: proportion of patients completing allocated pathway (target 80%). Primary outcome, Efficacy Phase: time to correct treatment, defined as TURBT for NMIBC or the first of chemotherapy, radiotherapy, surgery or decision for palliative care for MIBC (target: 30 day improvement).
Between May 2018 and December 2021, 143 patients were randomised, median age 74 years, 47.9% probable NMIBC, 52.1% possible MIBC. Feasibility phase: 37/39 (95% (95% CI 83-99%)) patients with MIBC followed correct pathway. Efficacy phase: Pathway 1, median time to correct MIBC treatment 98 (95% CI 72-174) days; Pathway 2 53 (95% CI 20-89) days, hazard ratio (HR) 3.4 (95% CI 1.4-8.3). Logrank test: p-value= 0.0046. Secondary outcomes include median time to correct treatment all patients: Pathway 1 37 days, Pathway 2 31 days; HR 1.3 (95% CI 0.9-1.8).
An MRI directed pathway led to substantial shortening of time to correct treatment for MIBC patients with no detrimental effect of time to treatment for NMIBC patients. Consideration should be given to incorporation of MRI into the standard pathway for all patients with suspected invasive bladder cancer.
Clinical trial identification