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

Muscle-invasive Bladder Cancer Clinical Trial

— PET MUSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02462239
• Other study ID #: OCOG-2013-PETMUSE
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2016
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 292
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Muscle-invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Whole-body FDG PET-CT

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Cancer Care Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in planned management	Assess change in planned management with actual treatment delivered in both pre-operative PET-CT versus no PET-CT (control) patients.	5 years
Other	Clinical and pathology response to chemotherapy using interim response of FDG PET-CT after 2 cycles of chemotherapy	Explore if interim response on FDG PET-CT after 2 cycles of chemotherapy is associated with clinical and pathology response to chemotherapy and if early interim metabolic response correlates with other outcome measures including DFS and OS.	5 years
Primary	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	Disease-free survival	Disease-free survival defined as objectively defined (RECIST criteria, version 1.1.) local or distant recurrence or death.	5 years
Secondary	Overall survival	Overall survival defined by all-cause mortality.	5 years
Secondary	Quality of life analysis	Overall QOL assessed using the EORTC QLQ-C30 version 3.	5 years
Secondary	Health economic analysis	Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.	5 years