Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer

Recruiting now · Phase 3

Conditions studied: Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy, Bladder Carcinoma, Bladder Neoplasm, Muscle Invasive Bladder Cancer (MIBC)

In brief

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.

Key facts

Study ID

NCT07067749

Run by

University of Rome Tor Vergata

People needed

92

Starts

2025-08-15

Expected to finish

2030-08-15

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging

You may not qualify if…

• Anticipated survival < 3 months due to comorbidities
• Pregnant patients
• Breastfeeding patients
• Previous chemotherapy within 6 weeks
• Previous radiotherapy withing 6 weeks
• Previous TURBt within 6 weeks
• Severe renal impairment (eGFR < 40 mL/min/1.73 m2)
• non MRI-compatible metal implants
• Claustrophobia
• Denial of written consent to participate in the study

Where it is running

• Policlinico Tor Vergata — Rome, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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