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

• ClinicalTrials.gov Identifier: NCT02462239
• Recruitment Status: Active, not recruiting
• First Posted: June 4, 2015
• Last Update Posted: March 28, 2023
• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Cancer Care Ontario
• Information provided by (Responsible Party): Ontario Clinical Oncology Group (OCOG)

Tracking Information

• First Submitted Date: May 27, 2015
• First Posted Date: June 4, 2015
• Last Update Posted Date: March 28, 2023
• Actual Study Start Date: May 6, 2016
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 3, 2018)

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).

Original Primary Outcome Measures (submitted: June 1, 2015)

Treatment received [ Time Frame: 5 years ]

Treatment received including: avoidance of cystectomy, more extensive lymph node dissection, or neoadjuvant chemotherapy followed by cystectomy.

Current Secondary Outcome Measures (submitted: June 1, 2015)

• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 1, 2015)

• Change in planned management [ Time Frame: 5 years ]
  Assess change in planned management with actual treatment delivered in both pre-operative PET-CT versus no PET-CT (control) patients.
• Clinical and pathology response to chemotherapy using interim response of FDG PET-CT after 2 cycles of chemotherapy [ Time Frame: 5 years ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
• Official Title: Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Muscle-invasive Bladder Cancer

Intervention

Other: Whole-body FDG PET-CT

Other Name: PET-CT imaging

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 8, 2022): 292
• Original Estimated Enrollment (submitted: June 1, 2015): 291
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02462239
• Other Study ID Numbers: OCOG-2013-PETMUSE
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ontario Clinical Oncology Group (OCOG)
• Original Responsible Party: Same as current
• Current Study Sponsor: Ontario Clinical Oncology Group (OCOG)
• Original Study Sponsor: Same as current
• Collaborators: Cancer Care Ontario

Investigators

• Principal Investigator: Srikala Sridhar, MD; Princess Margaret Hospital, Canada
• Principal Investigator: Nicholas Power, MD; LHSC-Victoria Hospital
• Principal Investigator: Som Mukherjee, MD; Juravinski Cancer Centre
• Principal Investigator: Ur Metser, MD; Princess Margaret Hospital, Canada
• Study Director: Mark Levine, MD; Ontario Clinical Oncology Group (OCOG)

• PRS Account: Ontario Clinical Oncology Group (OCOG)
• Verification Date: March 2022