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

Summary

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.

Conditions

• Bladder (Urothelial, Transitional Cell) Cancer
• Bladder Cancer Requiring Cystectomy
• Bladder Carcinoma
• Bladder Neoplasm
• Muscle Invasive Bladder Cancer (MIBC)

Interventions

DIAGNOSTIC_TEST

multiparametric magnetic resonance imaging (mpMRI) of the bladder

This 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.

PROCEDURE

Transurethral resection of bladder tumour (TURBt)

This 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.

GENETIC

Circulating tumour DNA levels assessment

Blood 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.

Sponsors & Collaborators

• University of Rome Tor Vergata

  lead OTHER

Principal Investigators

• Simone Albisinni, MD, Phd, FEBU · Fondazione PTV Policlinico Tor Vergata

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-15

Primary Completion

2028-08-15

Completion

2030-08-15

Countries

• Italy

Study Locations