MRI-Guided Bladder Preservation Program For Patients With Muscle Invasive Bladder Cancer

NCT07026864 | Not Yet Recruiting

• 1 other identifier: 2024.110
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain their bladders

Conditions

Muscle Invasive Bladder Cancer (MIBC)

Keywords

Muscle Invasive Bladder Cancer; Bladder Preservation; Radiation Therapy; MR-Guided Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate and Urinary and Rectal Toxicity

  A. To achieve pathological complete response rate in 95% of the patients. B. To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.

  Five years

Secondary Outcomes (1)

• Blood and urine biomarkers, Radiomics biomarkers and PROMs

  5 years

Study Arms (1)

MRI-guided Bladder Cancer Preservation Program

EXPERIMENTAL

Radiation: MR-guided Radiation Therapy

Interventions

MR-guided Radiation Therapy RADIATION

MR-guided Radiation Therapy

MRI-guided Bladder Cancer Preservation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2-T3N0M0 unifocal bladder cancer of any histologic subtype except squamous cell carcinoma or adenocarcinoma (Janopaul-Naylor et al., 2021) treated the maximal TURBT and able to tolerate concurrent chemoradiotherapy. Selected patients with high risk of common iliac involvement (T4 disease and/or limited N+ disease and/or LVSI+ status) able to receive the following treatment may be included as well. Additional criteria include:
• Karnofsky performance status \> 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
• WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.

You may not qualify if:

• Prior radiation therapy to the target areas;
• Inability to undergo a MRI exam

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Officials

• Rafael Martínez-Monge, M.D.

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

• Marta Moreno-Jiménez, M.D.

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Ramos Aguirre, M.S.

CONTACT

+34 948255400; ucicec@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, Radiation Oncology Department

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: July 1st, 2025 - June 30th, 2030
• Access Criteria: On request