Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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 criteria
Qualifiers
Patients (18+ years of age)
Clinically suspected MIBC
No lymph node or distant metastases
Written informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- mpMRI plus a same-day cystoscopic bladder biopsy
- TURBT
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov