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

Not Applicable

Completed

• Conditions: Muscle-invasive Bladder Cancer
• Interventions: Other: Whole-body FDG PET-CT

• Registration Number: NCT02462239
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-04
• Study Start: 2016-05-06
• Primary Completion: 2024-03-31
• Status Verified: 2024-11
• Study Completion: 2024-11-14
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole-body FDG PET-CT	Whole-body FDG PET-CT	Whole-body FDG PET-CT (Experimental arm)

Primary Outcome Measures

Name	Time	Method
Treatment received	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 Outcome Measures

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

Trial Locations

Locations (6)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada

Ottawa Hospital Regional Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada