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NCT Number: NCT05779631

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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Muscle-invasive Bladder Cancer Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeroen Bosch ziekenhuis, 's-Hertogenbosch, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mpMRI plus a same-day cystoscopic bladder biopsy

Diagnostic Test

mpMRI plus a same-day cystoscopic bladder biopsy

TURBT

Procedure

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

Primary outcomes

  1. Progression free survival

    Time frame: 2 years

    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

Secondary outcomes

  1. Time to definitive treatment

    Time frame: 2 years

    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.

  2. Health-related quality of life

    Time frame: 2 years

    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.

  3. Hospital-related healthcare costs

    Time frame: 2 years

    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.

  4. Cost-effectiveness

    Time frame: 2 years

    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).

  5. Circulating tumor cells

    Time frame: Before (at least on same day) and after (max. 60 minutes) TURBT

    Percentage of patients with CTCs/CTC clusters in the blood sample post-TURBT, among those who were CTC-free pre-TURBT, analysed by blood withdrawal shortly before and after TURBT.

  6. Metastatic potential of CTC-positive samples

    Time frame: Before (at least on same day) and after (max. 60 minutes) TURBT

    Post-TURBT CTC-positive samples of patients that were CTC negative prior to TURBT will be further analyzed for the expression levels of bladder cancer metastasis-associated genes using principal component- and heatmap analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

A. G. van der Heijden, Dr.

CONTACT

[email protected]

+31 (0)24 361 37 35

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: BladParadigm

Important dates

Study start
2023
Primary completion
2028
Study completion
2031
First posted
Mar 22, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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