The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes.
A blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.
Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging
Anticipated survival < 3 months due to comorbidities
Pregnant patients
Breastfeeding patients
Previous chemotherapy within 6 weeks
Parallel
multiparametric magnetic resonance imaging (mpMRI) of the bladder
Diagnostic testThis study will investigate the role of bladder mpMRI as a tool to expedite treatment in patients with muscle invasive bladder cancer. mpMRIs will be investigated as a possible replacement of standard TURBt, a planned surgical procedure for cancer local staging. mpMRis will be reported according to the Vesical Imaging - Reporting and Data System Stanrdars (VI-RADS) to provide a score indicating probability of muscle invasion.
Transurethral resection of bladder tumour (TURBt)
Procedure/SurgeryThis is a planned endoscopic surgical procedure consisting in resection of the bladder tumour through a electrified loop manouvred with an endoscope. In muscle invasive bladder cancer, this procedure allows histological confirmation of presence of detrusor muscle invasion.
Circulating tumour DNA levels assessment
GeneticBlood samples will be collected from each enrolled patient at pre-planned time points: 1. Cystoscopy, both arms 2. mpMRI (experimental arm) or TURBt (control arm) 3. Definite cancer treatment, both arms ctDNA levels will be measured on the collected blood samples.
Time to definitive treatment
Time in days needed to complete the diagnostic pathway, multidisciplinary board discussion and finally offer the appropriate definitive treatment for muscle invasive bladder cancer: surgery, drugs, radiation, palliative care
Concentration of ctDNA levels
ctDNA leves from blood samples collected at pre-planned time points in both arms
Cancer Specific Survival
Length of time from enrolment to the date of death from the disease.
Overall Survival
Length of time from enrolment to the date of death from any cause
Time to cancer recurrence
Length of time from enrolment to the date of clinically proven cancer recurrence
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