Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

Study Overview
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Brief Summary
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To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Detailed Description
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To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Official Title
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Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: mpMRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer (clinical T2-T3, any N) or high risk non-muscle invasive bladder cancer (pT1 or CIS) no known diagnosis of prostate cancer no contraindication to undergo multiparametric MRI Signed written informed consent prior to any screening procedures being performed Patient affiliated to the ''National security'' regimen or beneficiary of this regimen Exclusion Criteria: allergy against MR contrast media diagnosis or previous treatment of prostate cancer severe renal insufficiency (GFR <30ml/min) Bladder cancer infiltrating the prostate (T4) Pelvic metallic implants such as hip prosthesis Patients scheduled for cystoprostatectomy with prostate capsule sparing Patients unable to provide informed consent Patients having a prostate biopsy <6 month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Per patient analysis in a prospective, multicenter cohort, open study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mpMRI<br>mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen | Device: mpMRI<br>* mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference | The true negative and false negative rates of mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen as a reference in patients with no previous diagnosis of prostate cancer. | From the date of mpMRI exam (Day-1) to the date pathology report of Day 0 surgery is obtained (an average of 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiparametric MRI, cystoprostatectomy