Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)

Radboud University Medical Center

Status: Enrolling

Conditions: Muscle-invasive Bladder Cancer; Bladder Cancer

Treatments: Procedure: TURBT; Diagnostic Test: mpMRI plus a same-day cystoscopic bladder biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05779631

2022-15859

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

mpMRI plus a same-day cystoscopic bladder biopsy

Experimental group

Description:

multiparametric MRI plus same-day cystoscopic bladder biopsy

Treatment:

Diagnostic Test: mpMRI plus a same-day cystoscopic bladder biopsy

TURBT

Active Comparator group

Description:

Transurethral resection of the bladder tumor, blood withdrawal shortly before and after TURBT

Treatment:

Procedure: TURBT