Muscle-Invasive Bladder CarcinomaPhase 2EFFORT-MIBCNCT04724928
Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
A Phase 2 study testing Metastasis directed therapy (MDT) and Immunotherapy in people with Muscle-Invasive Bladder Carcinoma, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- What is being tested?
- Metastasis directed therapy (MDT) and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Apr 2021to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment
- T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- Age > 18 years
- WHO 0-2
- Willingness to undergo 18F-FDG-PET-CT
- Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively
- Willingness and ability to provide a signed informed consent according to ICH/GCP and national/local regulations
Who cannot join
- Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- Refusal of or having contraindications to 18F-FDG-PET-CT
- Refusal of MDT or immunotherapy
- Prior radiotherapy unabling MDT
- Contraindications to radiotherapy (including active inflammatory bowel disease)
- Contraindications to immunotherapy
- Other primary tumor diagnosed < 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Flor Verghote, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Valerie Fonteyne, +3293323015, valerie.fonteyne@uzgent.be
About this study
Official title: Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial
Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Being tested
- Metastasis directed therapy (MDT), Immunotherapy, Standard of care
- Keywords
- 18F-FDG-PET-CT, Staging, Distand metastasis, Oligometastatic disease, Metastasis directed therapy, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastasis directed therapy (MDT)Radiation
Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Concurrently, the oligometastasis will be treated with stereotactic body radiotherapy or metastasectomy.
ImmunotherapyDrug
Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards immunotherapy will be initiated and regular follow up will be performed.
Standard of careProcedure or surgery
Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards regular follow up is performed.
| Study group | Role | What they receive |
|---|---|---|
| Non-metastatic MIBC | Active comparator | No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's Receives: Procedure: Standard of care |
| Oligo-metastatic MIBC on 18F-FDG-PET-CT | Experimental | No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's Receives: Radiation: Metastasis directed therapy (MDT) |
| Poly-metastatic MIBC on 18F-FDG-PET-CT | Experimental | No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of > 3 metastasis on 1 or both 18F FDG PET-CT 's Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Defined as the time from diagnosis of MIBC to death from any cause
Measured: 2 years
Secondary outcomes (9)
The number of patients with acute toxicity
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 3 months
The number of patients with late toxicity
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 5 years
Progression-free survival
Defined as appearance of local/locoregional recurrence diagnosed at CT-scan or cystoscopy in case of TMT or appearance of metastasis diagnosed at MIBC or non-MIBC-related imaging.
Measured: 5 years
Distant metastasis-free survival
Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging.
Measured: 5 years
Disease specific survival
Defined as time of diagnosis until death due to MIBC.
Measured: 5 years
Patient reported quality of life as per EORTC-QLQ C30
Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients
Measured: 5 years
Patient reported quality of life as per EORTC-QLQ BLM30
Validated questionnaire assessing the health-related QOL of muscle invasive bladder cancer patients
Measured: 5 years
Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases
Sensitivity/specificity of 18F-FDG-PET-CT
Measured: 3 months
Validation of predictive biomarkers
A biopsy specimen of the bladder, obtained after transurethral resection of the bladder (TURb),as well as urine and blood samples will be collected for validation of predictive biomarkers by evaluating the correlation between response to therapy and outcome (PFS, DMFS, DSS and OS) with in literature reported biomarkers determined on biopsy specimen of the bladder, obtained after TURb.
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 posted26 Jan 2021
- Study start29 Apr 2021
- Primary completion31 Dec 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Responsible party
- Sponsor
- Investigators
- Valerie Fonteyne, MD; PhD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724928
- Sponsor's protocol ID
- BC-07456
- Other IDs
- BC-07456
- Acronym
- EFFORT-MIBC
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verghote F, Poppe L, Verbeke S, Dirix P, Albersen M, De Meerleer G, Berghen C, Ost P, Villeirs G, De Visschere P, De Man K, De Maeseneer D, Rottey S, Van Praet C, Decaestecker K, Fonteyne V. Evaluating the impact of 18F-FDG-PET-CT on risk stratification and treatment adaptation for patients with muscle-invasive bladder cancer (EFFORT-MIBC): a phase II prospective trial. BMC Cancer. 2021 Oct 18;21(1):1113. doi: 10.1186/s12885-021-08861-x.
PubMed 34663254
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial
- ClinicalTrials.gov ID
- NCT04724928
- Acronym / sponsor ID
- EFFORT-MIBC / BC-07456
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Keywords
- 18F-FDG-PET-CT, Staging, Distand metastasis, Oligometastatic disease, Metastasis directed therapy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 26 Jan 2021 (actual)
- 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.
Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-metastatic MIBC | Active comparator | Procedure: Standard of careNo signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's |
| Oligo-metastatic MIBC on 18F-FDG-PET-CT | Experimental | Radiation: Metastasis directed therapy (MDT)No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's |
| Poly-metastatic MIBC on 18F-FDG-PET-CT | Experimental | Drug: ImmunotherapyNo signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of > 3 metastasis on 1 or both 18F FDG PET-CT 's |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment
- T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- Age > 18 years
- WHO 0-2
- Willingness to undergo 18F-FDG-PET-CT
Key exclusion criteria (7 listed)
- Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- Refusal of or having contraindications to 18F-FDG-PET-CT
- Refusal of MDT or immunotherapy
- Prior radiotherapy unabling MDT
- Contraindications to radiotherapy (including active inflammatory bowel disease)
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 |
|---|---|---|
| Metastasis directed therapy (MDT)Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Concurrently, the oligometastasis will be treated with stereotactic body radiotherapy or metastasectomy. | Radiation | Oligo-metastatic MIBC on 18F-FDG-PET-CT |
| ImmunotherapyPatient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards immunotherapy will be initiated and regular follow up will be performed. | Drug | Poly-metastatic MIBC on 18F-FDG-PET-CT |
| Standard of carePatient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards regular follow up is performed. | Procedure or surgery | Non-metastatic MIBC |
Primary outcome
Overall survival
Time frame: 2 years
Defined as the time from diagnosis of MIBC to death from any cause
9 secondary outcomes
The number of patients with acute toxicity
Time frame: 3 months
The number of patients with late toxicity
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Distant metastasis-free survival
Time frame: 5 years
Disease specific survival
Time frame: 5 years
Patient reported quality of life as per EORTC-QLQ C30
Time frame: 5 years
Patient reported quality of life as per EORTC-QLQ BLM30
Time frame: 5 years
Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases
Time frame: 3 months
Validation of predictive biomarkers
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 34663254Verghote F, Poppe L, Verbeke S, Dirix P, Albersen M, De Meerleer G, Berghen C, Ost P, Villeirs G, De Visschere P, De Man K, De Maeseneer D, Rottey S, Van Praet C, Decaestecker K, Fonteyne V. Evaluating the impact of 18F-FDG-PET-CT on risk stratification and treatment adaptation for patients with muscle-invasive bladder cancer (EFFORT-MIBC): a phase II prospective trial. BMC Cancer. 2021 Oct 18;21(1):1113. doi: 10.1186/s12885-021-08861-x.
- 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.
Flor Verghote, MD contact
Valerie Fonteyne, MD; PhD principal investigator
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metastasis directed therapy (MDT) and Immunotherapy in people with Muscle-Invasive Bladder Carcinoma, run by University Hospital, Ghent at 1 site in Belgium.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie Fonteyne, MD; PhD (+3293323015, valerie.fonteyne@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724928, which also lists 1 linked publication.
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 15 Jan 2025.