Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)
Radboud University Medical Center
360 participants
Dec 6, 2023
INTERVENTIONAL
Conditions
Summary
A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.
Eligibility
Inclusion Criteria4
- Patients (18+ years of age)
- Clinically suspected MIBC
- No lymph node or distant metastases
- Written informed consent
Exclusion Criteria4
- Unable or unwilling to undergo mpMRI
- Unfit for TURBT
- Unfit for definitive treatment with curative intent
- A history of cancer, including bladder cancer, except: non-melanoma skin cancer, prostate cancer on active surveillance or a solid malignant tumor ≥5 years disease-free since last treatment
Interventions
mpMRI plus a same-day cystoscopic bladder biopsy
Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT
Locations(19)
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NCT05779631