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NCT Number: NCT02462239

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

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.

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Key information

Conditions

Muscle-invasive Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-body FDG PET-CT

Other

Other names: PET-CT imaging

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Cancer Care Ontario

Registry information

Acronym: PET MUSE

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2015
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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