Clinical trial NCT02462239: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle-invasive Bladder Cancer
Keywords: Muscle-invasive bladder cancer
Bladder cancer
PET imaging
FDG
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Cancer Care Ontario
First posted: 2015-06-04
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment received
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Quality of life analysis
timeFrame: 5 years
measure: Health economic analysis
timeFrame: 5 years
Other outcomes:
measure: Change in planned management
timeFrame: 5 years
measure: Clinical and pathology response to chemotherapy using interim response of FDG PET-CT after 2 cycles of chemotherapy
timeFrame: 5 years
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Srikala Sridhar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LHSC-Victoria Hospital
name: Nicholas Power, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: Som Mukherjee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: Ur Metser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, MD
role: STUDY_DIRECTOR
References: