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

NCT02462239 | Completed DMC

• 1 other identifier: OCOG-2013-PETMUSE
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 6

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.

Conditions

Muscle-invasive Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease-free survival

  5 years

• Overall survival

  5 years

• Quality of life analysis

  5 years

• Health economic analysis

  5 years

Other Outcomes (2)

• Change in planned management

  5 years

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

  5 years

Study Arms (2)

Whole-body FDG PET-CT

EXPERIMENTAL

Whole-body FDG PET-CT (Experimental arm)

Other: Whole-body FDG PET-CT

No PET-CT

NO INTERVENTION

No PET-CT (Control arm)

Interventions

Whole-body FDG PET-CT OTHER

Also known as: PET-CT imaging

Whole-body FDG PET-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Cancer Care Ontario: collaborator

Study Sites (6)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Mark Levine, MD

  Ontario Clinical Oncology Group (OCOG)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 4, 2015
• Study Start: May 6, 2016
• Primary Completion: March 31, 2024
• Study Completion: November 14, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)