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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of ctDNA levels | ctDNA leves from blood samples collected at pre-planned time points in both arms | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Albisinni, MD, Phd, FEBU | Contact | +390620902977 | simone.albisinni@ptvonline.it | |
| Luca Orecchia, MD | Contact | +390620902978 | luca.orecchia@ptvonline.it |
| Name | Affiliation | Role |
|---|---|---|
| Simone Albisinni, MD, Phd, FEBU | Fondazione PTV Policlinico Tor Vergata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Tor Vergata | Recruiting | Rome | RM | 00133 | Italy |
Individual patient data to be released to other parties upon reasonable request to the Principal Investigatorand Local Ethics Board approval
IPD and supporting information available from study completion on August 2030 for 10 years
Individual patient data to be released to other parties upon reasonable request to the Principal Investigator and Local Ethics Board approval
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Single centre, parallel, two-arm randomised controlled trial
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| 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. |
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| Circulating tumour DNA levels assessment | Genetic | Blood samples will be collected from each enrolled patient at pre-planned time points:
ctDNA levels will be measured on the collected blood samples. |
|
Length of time from enrolment to the date of death from the disease. |
| through study completion, an average of 2 years |
| Overall Survival | Length of time from enrolment to the date of death from any cause | through study completion, an average of 2 years |
| Time to cancer recurrence | Length of time from enrolment to the date of clinically proven cancer recurrence | "through study completion, an average of 2 years". |
| Number of procedure Related Complications | Monitoring of procedure related complications for TURBt and mpMRI | For 30 days following the procedure |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| D000094463 | Transurethral Resection of Bladder |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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