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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Detailed Description

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.

Interventions

  • Other: Whole-body FDG PET-CT

Arms, Groups and Cohorts

  • Experimental: Whole-body FDG PET-CT
    • Whole-body FDG PET-CT (Experimental arm)
  • No Intervention: No PET-CT
    • No PET-CT (Control arm)

Clinical Trial Outcome Measures

Primary Measures

  • Treatment received
    • Time Frame: 5 years
    • 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).

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ontario Clinical Oncology Group (OCOG)
  • Collaborator
    • Cancer Care Ontario
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Srikala Sridhar, MD, Principal Investigator, Princess Margaret Hospital, Canada
    • Nicholas Power, MD, Principal Investigator, LHSC-Victoria Hospital
    • Som Mukherjee, MD, Principal Investigator, Juravinski Cancer Centre
    • Ur Metser, MD, Principal Investigator, Princess Margaret Hospital, Canada
    • Mark Levine, MD, Study Director, Ontario Clinical Oncology Group (OCOG)

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