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

NCT ID: NCT07067749

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2030-08-15

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Management

Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.

They will be booked for TURBt and be managed according to international guidelines.

If the pathology report of the TURBt will show muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.

Treatment will be discussed with patients in a shared decision making context and booked.

Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT.

Group Type: ACTIVE_COMPARATOR

Transurethral resection of bladder tumour (TURBt)

Intervention Type: PROCEDURE

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.

Circulating tumour DNA levels assessment

Intervention Type: GENETIC

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.

Simplified Management

Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.

They will be booked for bladder mpMRI through a dedicated service at the sponsor Institution to assess the suspiscion detrusor muscle invasion by the tumour.

If the pathology report of the biopsy will show cancer and the mpMRI will confirm a high degree of suspicion for muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.

Treatment will be discussed with patients in a shared decision making context and booked.

Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT.

Group Type: EXPERIMENTAL

multiparametric magnetic resonance imaging (mpMRI) of the bladder

Intervention Type: DIAGNOSTIC_TEST

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.

Circulating tumour DNA levels assessment

Intervention Type: GENETIC

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: PROCEDURE

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.

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rome Tor Vergata

OTHER

Sponsor Role: lead

Responsible Party

Simone Albisinni

Associate Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Albisinni, MD, Phd, FEBU

Role: PRINCIPAL_INVESTIGATOR

Fondazione PTV Policlinico Tor Vergata

Locations

Policlinico Tor Vergata

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Simone Albisinni, MD, Phd, FEBU

Role: CONTACT

simone.albisinni@ptvonline.it

+390620902977

Luca Orecchia, MD

Role: CONTACT

luca.orecchia@ptvonline.it

Facility Contacts

Simone Albisinni, Associate Professor of Urology

Role: primary

simone.albisinni@ptvonline.it

06020902977

Other Identifiers

315.24CET2 ptv

Identifier Type: -

Identifier Source: org_study_id