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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinica Universidad de Navarra, Universidad de Navarra

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior radiation therapy to the target areas;

Inability to undergo a MRI exam

Trial design

Design model

Single group

Treatments tested in this trial

  • MR-guided Radiation Therapy

    Radiation

    MR-guided Radiation Therapy

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: MRI-guided Bladder Cancer Preservation ProgramExperimental treatment 1 intervention

Trial outcomes

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%.

Time frame
Five years

Secondary outcomes

1

Blood and urine biomarkers, Radiomics biomarkers and PROMs

A. Determination of blood and urine biomarkers of treatment response and toxicity . B. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of urinary functionality with IPSS and Bladder Control Self-Assessment Questionnaire

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: