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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 | Clinical Trials | Clareo Health

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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

NCT03960112•Institut Paoli-Calmettes

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

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

Locations (5)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, France

CHRU Hopital Edouard Herriot

Lyon, France

Hopital Nord

Marseille, France

Institut Mutualiste Montsouris

Paris, France

Chu Saint Etienne

Saint-Etienne, France

Key Dates

Start Date

October 1, 2020

Primary Completion Date

October 1, 2022

Completion Date

December 1, 2022

Last Updated

July 28, 2020

Enrollment

150

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

mpMRI

DEVICE

Contacts

Dominique GENRE, MD

CONTACT

33 (0)4 91 22 37 78 DRCI.UP@ipc.unicancer.fr

Margot BERLINE, MSc, MBA

CONTACT

33 (0)4 91 22 33 14 BERLINEM@ipc.unicancer.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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