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

NCT07067749 | Recruiting Phase 3 DMC

• 1 other identifier: 315.24CET2 ptv
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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)

Keywords

Muscle Invasive Bladder Cancer; VI-RADS; Bladder Magnetic Resonance Imaging; Cystectomy; TURBT; treatment expedition; cancer management optimisation; circulating tumour DNA

Outcome Measures

Primary Outcomes (1)

• 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

  From the day of enrollment at baseline until the day of the start of definitive treatment for muscle invasive bladder cancer. Expected timeframe between 45 and 180 days.

Secondary Outcomes (5)

• Concentration of ctDNA levels

  Three specific time points: 1) Enrolment at baseline 2) During intervention (mpMRI or TURBt) 3) On the day of definitive treatment for muscle invasive cancer Expected timeframe 1 to 180 days

• Cancer Specific Survival

  through study completion, an average of 2 years

• Overall Survival

  through study completion, an average of 2 years

• Time to cancer recurrence

  "through study completion, an average of 2 years".

• Number of procedure Related Complications

  For 30 days following the procedure

Study Arms (2)

Standard Management

ACTIVE COMPARATOR

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.

Procedure: Transurethral resection of bladder tumour (TURBt); Genetic: Circulating tumour DNA levels assessment

Simplified Management

EXPERIMENTAL

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.

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

Interventions

multiparametric magnetic resonance imaging (mpMRI) of the bladder 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.

Simplified Management

Transurethral resection of bladder tumour (TURBt) 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.

Standard Management

Circulating tumour DNA levels assessment 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; Standard Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Policlinico Tor Vergata

Rome, RM, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms; Urinary Bladder Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging; Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Simone Albisinni, MD, Phd, FEBU

  Fondazione PTV Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Albisinni, MD, Phd, FEBU

CONTACT

+390620902977; simone.albisinni@ptvonline.it

Luca Orecchia, MD

CONTACT

luca.orecchia@ptvonline.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Model Details: Single centre, parallel, two-arm randomised controlled trial

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 16, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2030
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information available from study completion on August 2030 for 10 years
• Access Criteria: Individual patient data to be released to other parties upon reasonable request to the Principal Investigator and Local Ethics Board approval

Locations

IT (1)