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

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle-Invasive Bladder Carcinoma
• Intervention / Treatment: Procedure: Standard of care; Radiation: Metastasis directed therapy (MDT); Drug: Immunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Valerie Fonteyne, MD; PhD; Phone Number: +3293323015; Email: valerie.fonteyne@uzgent.be
• Study Contact Backup: Name: Flor Verghote, MD; Email: flor.verghote@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Valerie Fonteyne; Phone Number: +3293323015; Email: valerie.fonteyne@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-metastatic MIBC; No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's	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.
Experimental: Oligo-metastatic MIBC on 18F-FDG-PET-CT; 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	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.
Experimental: Poly-metastatic MIBC on 18F-FDG-PET-CT; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Defined as the time from diagnosis of MIBC to death from any cause	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients with acute toxicity	Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	3 months
The number of patients with late toxicity	Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	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.	5 years
Distant metastasis-free survival	Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging.	5 years
Disease specific survival	Defined as time of diagnosis until death due to MIBC.	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	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	5 years
Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases	Sensitivity/specificity of 18F-FDG-PET-CT	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.	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Kom Op Tegen Kanker
• Investigators: Principal Investigator: Valerie Fonteyne, MD; PhD, UZ Ghent

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Immunotherapy; Staging; Oligometastatic disease; 18F-FDG-PET-CT; Distand metastasis; Metastasis directed therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Immunologic Factors; Physiological Effects of Drugs; Immunomodulating Agents
• Other Study ID Numbers: BC-07456 (Other Identifier: Ethics committee of the Ghent University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No