Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging

Study Overview
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Brief Summary
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Bladder cancer is the fifth most common cancer in Canada and there has been relatively little progress in altering its clinical course over the last three decades. One of the major problems identified in the management of this disease, is under staging of muscle invasive disease which can lead to suboptimal treatment and outcomes. PET-CT has the potential to more accurately stage MIBC than standard CT by detecting pelvic adenopathy and/or distant sites of disease that may not be found on standard imaging. In the former situation, more aggressive therapy with extended lymph node dissection and/or neoadjuvant chemotherapy prior to cystectomy can be offered. While in the latter situation patients can be spared the morbidity of a cystectomy performed in a setting of metastatic disease. This study will address whether PET-CT adds a clinically meaningful difference in care.

Detailed Description
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A multicenter randomized controlled trial will be performed. Patients usually present with symptoms (e.g., painless hematuria). The urologist will perform cystoscopy and if urothelial cancer of the bladder is suspected, the patient is taken to the operating room for an examination under anesthesia (EUA) and a TURBT. If this shows muscle invasion then conventional staging with CT chest, abdomen, and pelvis is performed. The patient who has TNM Stage T2a-T4a N0-3 M0 is eligible to be enrolled in the trial. Eligible consenting patients will be randomized 2:1 to PET-CT or none (Control). The actual treatment received by the patient will be documented. The primary outcome measure is treatment received.

Official Title
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Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging

Conditions
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Muscle-invasive Bladder Cancer

Intervention / Treatment
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* Other: Whole-body FDG PET-CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with newly diagnosed muscle-invasive high grade urothelial carcinoma of the bladder (TNM stage T2a-T4a, N0-3, M0), who are eligible for either radical cystectomy or radiotherapy-based bladder conservation. Being considered for treatment of curative intent. Exclusion Criteria: Age < 18 years. ECOG performance status >2. Predominant histology (>50% of specimen) involves non-urothelial cell carcinoma. Prior partial cystectomy. Prior pelvis surgery that obviates a completed extended lymphadenectomy (e.g., aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised. Contraindications to FDG PET-CT. Inability to lie supine for imaging with PET-CT. Inadequate hepatic function: (i) Bilirubin >1.5 X ULN and (ii) SGOT and Alkaline phosphatase >3 X ULN History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer. Known pregnancy or lactating female. Inability to complete the study or required follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-body FDG PET-CT<br>Whole-body FDG PET-CT (Experimental arm) | Other: Whole-body FDG PET-CT<br> <br> * Other names: PET-CT imaging;|
| No Intervention: No PET-CT<br>No PET-CT (Control arm) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment received | For patients with planned cystectomy, treatment received includes: avoidance of planned cystectomy and node dissection, an extended (vs standard) node dissection (or standard dissection when extended is the surgeon's usual practice), use of neoadjuvant chemotherapy (vs no neoadjuvant chemotherapy). For patients with planned bladder conservation, treatment received includes: avoidance of bladder and nodal radiation (vs bladder only or no radiation) and use of neoadjuvant chemotherapy (or not). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival defined as objectively defined (RECIST criteria, version 1.1.) local or distant recurrence or death. | 5 years | 
| Overall survival | Overall survival defined by all-cause mortality. | 5 years | 
| Quality of life analysis | Overall QOL assessed using the EORTC QLQ-C30 version 3. | 5 years | 
| Health economic analysis | Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle-invasive bladder cancer, Bladder cancer, PET imaging, FDG