Muscle-invasive Bladder CancerPET MUSENCT02462239
Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
A study testing Whole-body FDG PET-CT in people with Muscle-invasive Bladder Cancer, run by Ontario Clinical Oncology Group (OCOG) at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-invasive Bladder Cancer
- What is being tested?
- Whole-body FDG PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 6 sitesCanada
- Study dates
- 6 May 2016to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Inability to lie supine for imaging with PET-CT.
- Inadequate hepatic function:
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Regional Cancer Centre
London, Ontario, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
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.
Read the 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.
- Conditions
- Muscle-invasive Bladder Cancer
- Being tested
- Whole-body FDG PET-CT
- Keywords
- Muscle-invasive bladder cancer, Bladder cancer, PET imaging, FDG
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body FDG PET-CTOther
Also called PET-CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Whole-body FDG PET-CT | Experimental | Whole-body FDG PET-CT (Experimental arm) Receives: Other: Whole-body FDG PET-CT |
| No PET-CT | No intervention | No PET-CT (Control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
Secondary outcomes (4)
Disease-free survival
Disease-free survival defined as objectively defined (RECIST criteria, version 1.1.) local or distant recurrence or death.
Measured: 5 years
Overall survival
Overall survival defined by all-cause mortality.
Measured: 5 years
Quality of life analysis
Overall QOL assessed using the EORTC QLQ-C30 version 3.
Measured: 5 years
Health economic analysis
Health economic analysis assessed using EQ-5D health utility questionnaire and total healthcare costs.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study start6 May 2016
- Primary completion31 Mar 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Care Ontario
- Responsible party
- Sponsor
- Investigators
- Srikala Sridhar, MD, Principal investigator, Princess Margaret Hospital, CanadaNicholas Power, MD, Principal investigator, LHSC-Victoria HospitalSom Mukherjee, MD, Principal investigator, Juravinski Cancer CentreUr Metser, MD, Principal investigator, Princess Margaret Hospital, CanadaMark Levine, MD, Study director, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462239
- Sponsor's protocol ID
- OCOG-2013-PETMUSE
- Acronym
- PET MUSE
- Status last verified
- Nov 2024
- First submitted
- 27 May 2015
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
- ClinicalTrials.gov ID
- NCT02462239
- Acronym / sponsor ID
- PET MUSE / OCOG-2013-PETMUSE
- Conditions
- Muscle-invasive Bladder Cancer
- Keywords
- Muscle-invasive bladder cancer, Bladder cancer, PET imaging, FDG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Cancer Care Ontario
- Study start
- 6 May 2016 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body FDG PET-CT | Experimental | Other: Whole-body FDG PET-CTWhole-body FDG PET-CT (Experimental arm) |
| No PET-CT | No intervention | –No PET-CT (Control arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body FDG PET-CTAlso: PET-CT imaging | Other | Whole-body FDG PET-CT |
Primary outcome
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).
4 secondary outcomes
Disease-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life analysis
Time frame: 5 years
Health economic analysis
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srikala Sridhar, MD principal investigator
Princess Margaret Hospital, Canada
Nicholas Power, MD principal investigator
LHSC-Victoria Hospital
Som Mukherjee, MD principal investigator
Juravinski Cancer Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body FDG PET-CT in people with Muscle-invasive Bladder Cancer, run by Ontario Clinical Oncology Group (OCOG) at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment received (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.