Clinical trial NCT03960112: Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
Official title: Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: multiparametric MRI
cystoprostatectomy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Per patient analysis in a prospective, multicenter cohort, open study.
Primary purpose: DIAGNOSTIC

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
timeFrame: From the date of mpMRI exam (Day-1) to the date pathology report of Day 0 surgery is obtained (an average of 7 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
city: Lyon
country: France
facility: CHRU Hopital Edouard Herriot
city: Marseille
country: France
facility: Hopital Nord
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jochen WALZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
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