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: April 20, 2022
• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Cancer Care Ontario
• Information provided by (Responsible Party): Ontario Clinical Oncology Group (OCOG)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Muscle-invasive Bladder Cancer	Other: Whole-body FDG PET-CT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 292 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
• Actual Study Start Date: May 6, 2016
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Whole-body FDG PET-CT; Whole-body FDG PET-CT (Experimental arm)	Other: Whole-body FDG PET-CT; Other Name: PET-CT imaging
No Intervention: No PET-CT; No PET-CT (Control arm)

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. Overall survival [ Time Frame: 5 years ]
   Overall survival defined by all-cause mortality.
3. Quality of life analysis [ Time Frame: 5 years ]
   Overall QOL assessed using the EORTC QLQ-C30 version 3.
4. Health economic analysis [ Time Frame: 5 years ]
   Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.

Other Outcome Measures:

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

London Regional Cancer Centre

London, Ontario, Canada, N6A 4L6

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada, K1H 8L6

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada, P7B 6V4

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

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)

More Information

• Responsible Party: Ontario Clinical Oncology Group (OCOG)
• ClinicalTrials.gov Identifier: NCT02462239
• Other Study ID Numbers: OCOG-2013-PETMUSE
• First Posted: June 4, 2015
• Last Update Posted: April 20, 2022
• Last Verified: March 2022

Keywords provided by Ontario Clinical Oncology Group (OCOG):

Muscle-invasive bladder cancer; Bladder cancer; PET imaging; FDG

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Urologic Diseases