Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC)

Ghent University Hospital (UZ)

Status and phase: Enrolling; Phase 2

Conditions: Muscle-Invasive Bladder Carcinoma

Treatments: Radiation: Metastasis directed therapy (MDT); Drug: Immunotherapy; Procedure: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04724928

BC-07456 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 3 patient groups

Non-metastatic MIBC

Active Comparator group

Description:

No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's

Treatment:

Procedure: Standard of care

Oligo-metastatic MIBC on 18F-FDG-PET-CT

Experimental group

Description:

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

Treatment:

Radiation: Metastasis directed therapy (MDT)

Poly-metastatic MIBC on 18F-FDG-PET-CT

Experimental group

Description:

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

Treatment:

Drug: Immunotherapy