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NCT Number: NCT04724928

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

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.

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Key information

Conditions

Muscle-Invasive Bladder Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Valerie Fonteyne

CONTACT

[email protected]

+3293323015

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Overall survival

    Time frame: 2 years

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

Secondary outcomes

  1. The number of patients with acute toxicity

    Time frame: 3 months

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. The number of patients with late toxicity

    Time frame: 5 years

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  3. Progression-free survival

    Time frame: 5 years

    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.

  4. Distant metastasis-free survival

    Time frame: 5 years

    Defined as time of diagnosis until occurrence of distant metastasis on repeated imaging.

  5. Disease specific survival

    Time frame: 5 years

    Defined as time of diagnosis until death due to MIBC.

  6. Patient reported quality of life as per EORTC-QLQ C30

    Time frame: 5 years

    Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients

  7. Patient reported quality of life as per EORTC-QLQ BLM30

    Time frame: 5 years

    Validated questionnaire assessing the health-related QOL of muscle invasive bladder cancer patients

  8. Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases

    Time frame: 3 months

    Sensitivity/specificity of 18F-FDG-PET-CT

  9. Validation of predictive biomarkers

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Flor Verghote, MD

CONTACT

[email protected]

Valerie Fonteyne, MD; PhD

CONTACT

[email protected]

+3293323015

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Kom Op Tegen Kanker

Registry information

Official study 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

Acronym: EFFORT-MIBC

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Jan 26, 2021
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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