Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients With Muscle Invasive Bladder Cancer

Muscle-Invasive Bladder Carcinoma Clinical Trial

— EFFORT-MIBC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724928
• Other study ID #: BC-07456
• Secondary ID: BC-07456
• Status: Recruiting
• Phase: Phase 2
• Start date: April 29, 2021
• Est. completion date: May 2030

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Valerie Fonteyne, MD; PhD
• Phone: +3293323015
• Email: valerie.fonteyne[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: May 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle-Invasive Bladder Carcinoma
• Urinary Bladder Neoplasms

Intervention

Radiation:
• 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.

Drug:
• Immunotherapy
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.

Procedure:
• Standard of care
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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Kom Op Tegen Kanker

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Defined as the time from diagnosis of MIBC to death from any cause	2 years
Secondary	The number of patients with acute toxicity	Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	3 months
Secondary	The number of patients with late toxicity	Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	5 years
Secondary	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.	5 years
Secondary	Distant metastasis-free survival	Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging.	5 years
Secondary	Disease specific survival	Defined as time of diagnosis until death due to MIBC.	5 years
Secondary	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	5 years
Secondary	Patient reported quality of life as per EORTC-QLQ BLM30	Validated questionnaire assessing the health-related QOL of muscle invasive bladder cancer patients	5 years
Secondary	Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases	Sensitivity/specificity of 18F-FDG-PET-CT	3 months
Secondary	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.	5 years