Health TrialsbyHealthPanel

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

ConditionsBladder CancerMuscle-invasive Bladder Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • mpMRI plus a same-day cystoscopic bladder biopsy

    Diagnostic test

    mpMRI plus a same-day cystoscopic bladder biopsy

  • TURBT

    Procedure/Surgery

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

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: mpMRI plus a same-day cystoscopic bladder biopsyExperimental treatment 1 intervention
Group B: TURBTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

Progression-free survival, defined as the time between randomisation and one of the following events, whichever occurs first: * Diagnosis of distant metastases * Diagnosis of loco-regional nodal recurrence * Death from any cause

Time frame
2 years

Secondary outcomes

1

Time to definitive treatment

Definitive treatment is defined as TURBT in case of NMIBC and radical cystectomy with or without neoadjuvant chemotherapy or chemoradiotherapy in case of MIBC. Time to definitive treatment is the time between randomisation and the first of these mentioned treatments.

Time frame
2 years
2

Health-related quality of life

Generic health-related quality of life will be assessed at baseline, 6 months, 12 months and 24 months using the EuroQol 5 dimensions 5 levels (EuroQol 5D) questionnaire.

Time frame
2 years
3

Hospital-related healthcare costs

Hospital registries will be used to identify all items / procedures / activities related to the management of the bladder cancer and obtain a valid and reliable estimate of the costs. Unit costs will be based on the Dutch manual for costing studies.

Time frame
2 years
4

Cost-effectiveness

Unit costs will be based on the Dutch manual for costing studies. Effectiveness will be measured in terms of quality-adjusted life years (QALYs), following the Dutch guideline for economic evaluation (EuroQol 5D).

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now