Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local
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.
| Condition(s) | Bladder Cancer, Muscle-invasive Bladder Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Patients (18+ years of age) * Clinically suspected MIBC * No lymph node or distant metastases * Written informed consent Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Radboud University Medical Center |
| Locations | 's-Hertogenbosch, Netherlands; Almelo, Netherlands; Amersfoort, Netherlands; Amsterdam, Netherlands; Amsterdam, Netherlands; Amsterdam, Netherlands (+13 more sites) |
| Start date | 2023-12-06 |
| NCT ID | NCT05779631 |
| Official listing | https://clinicaltrials.gov/study/NCT05779631 |