Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference (NPV-MRI-02)

Institut Paoli-Calmettes

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: mpMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03960112

NPV-MRI-02-IPC 2017-047

Details and patient eligibility

About

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

Full description

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

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age >18 years
2. 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)
3. no known diagnosis of prostate cancer
4. no contraindication to undergo multiparametric MRI
5. Signed written informed consent prior to any screening procedures being performed
6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen

Exclusion criteria

1. allergy against MR contrast media
2. diagnosis or previous treatment of prostate cancer
3. severe renal insufficiency (GFR <30ml/min)
4. Bladder cancer infiltrating the prostate (T4)
5. Pelvic metallic implants such as hip prosthesis
6. Patients scheduled for cystoprostatectomy with prostate capsule sparing
7. Patients unable to provide informed consent
8. Patients having a prostate biopsy <6 month

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

mpMRI

Experimental group

Description:

mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen

Treatment:

Device: mpMRI