Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer (TEMPO-MIBC)

University of Rome Tor Vergata

Status and phase: Enrolling; Phase 3

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

Treatments: Procedure: Transurethral resection of bladder tumour (TURBt); Diagnostic Test: multiparametric magnetic resonance imaging (mpMRI) of the bladder; Genetic: Circulating tumour DNA levels assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT07067749

315.24CET2 ptv

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Standard Management

Active Comparator group

Description:

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.

Treatment:

Genetic: Circulating tumour DNA levels assessment

Procedure: Transurethral resection of bladder tumour (TURBt)

Simplified Management

Experimental group

Description:

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.

Treatment:

Genetic: Circulating tumour DNA levels assessment

Diagnostic Test: multiparametric magnetic resonance imaging (mpMRI) of the bladder