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

NCT04724928 | Recruiting Phase 2

• 1 other identifier: BC-07456
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle-Invasive Bladder Carcinoma

Keywords

18F-FDG-PET-CT; Staging; Distand metastasis; Oligometastatic disease; Metastasis directed therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Defined as the time from diagnosis of MIBC to death from any cause

  2 years

Secondary Outcomes (9)

• The number of patients with acute toxicity

  3 months

• The number of patients with late toxicity

  5 years

• Progression-free survival

  5 years

• Distant metastasis-free survival

  5 years

• Disease specific survival

  5 years

Study Arms (3)

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

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

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

Drug: Immunotherapy

Interventions

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.

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

Immunotherapy DRUG

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.

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

Standard of care PROCEDURE

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.

Non-metastatic MIBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 34663254 DERIVED

MeSH Terms

Interventions

Immunotherapy; Standard of Care

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Valerie Fonteyne, MD; PhD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Fonteyne, MD; PhD

CONTACT

+3293323015; valerie.fonteyne@uzgent.be

Flor Verghote, MD

CONTACT

flor.verghote@uzgent.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: April 29, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)