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

Primary Purpose

Muscle-invasive Bladder Cancer

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Whole-body FDG PET-CT

About this trial

This is an interventional treatment trial for Muscle-invasive Bladder Cancer focused on measuring Muscle-invasive bladder cancer, Bladder cancer, PET imaging, FDG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Juravinski Cancer Centre
London Regional Cancer Centre
Ottawa Hospital Regional Cancer Centre
Thunder Bay Regional Health Sciences Centre
Sunnybrook Odette Cancer Centre
Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Whole-body FDG PET-CT

No PET-CT

Arm Description

Whole-body FDG PET-CT (Experimental arm)

No PET-CT (Control arm)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Disease-free survival

Disease-free survival defined as objectively defined (RECIST criteria, version 1.1.) local or distant recurrence or death.

Overall survival

Overall survival defined by all-cause mortality.

Quality of life analysis

Overall QOL assessed using the EORTC QLQ-C30 version 3.

Health economic analysis

Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.

Full Information

NCT ID

NCT02462239

First Posted

May 27, 2015

Last Updated

August 9, 2023

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Cancer Care Ontario

1. Study Identification

Unique Protocol Identification Number

NCT02462239

Brief Title

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

Acronym

PET MUSE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 6, 2016 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Cancer Care Ontario

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle-invasive Bladder Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

292 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole-body FDG PET-CT

Arm Type

Experimental

Arm Description

Whole-body FDG PET-CT (Experimental arm)

Arm Title

No PET-CT

Arm Type

No Intervention

Arm Description

No PET-CT (Control arm)

Intervention Type

Other

Intervention Name(s)

Whole-body FDG PET-CT

Other Intervention Name(s)

PET-CT imaging

Primary Outcome Measure Information:

Title

Treatment received

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Disease-free survival

Description

Disease-free survival defined as objectively defined (RECIST criteria, version 1.1.) local or distant recurrence or death.

Time Frame

5 years

Title

Overall survival

Description

Overall survival defined by all-cause mortality.

Time Frame

5 years

Title

Quality of life analysis

Description

Overall QOL assessed using the EORTC QLQ-C30 version 3.

Time Frame

5 years

Title

Health economic analysis

Description

Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Change in planned management

Description

Assess change in planned management with actual treatment delivered in both pre-operative PET-CT versus no PET-CT (control) patients.

Time Frame

5 years

Title

Clinical and pathology response to chemotherapy using interim response of FDG PET-CT after 2 cycles of chemotherapy

Description

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.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: