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)

July 27, 2020 updated by: Institut Paoli-Calmettes
To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69437
        • CHRU Hopital Edouard Herriot
        • Contact:
          • Marc COLOMBEL, Pr
        • Principal Investigator:
          • Marc COLOMBEL, Pr
      • Marseille, France, 13020
        • Hôpital Nord
        • Contact:
          • David Chemouni, MD
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
        • Contact:
          • Aude Fregeville, MD
      • Saint Etienne, France, 42055
        • CHU Saint Etienne
        • Contact:
          • Nicolas MOTTET-AUSELO, Dr
        • Principal Investigator:
          • Nicolas MOTTET-AUSELO, Dr
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mpMRI
mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
Device: mpMRI
mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen

What is the study measuring?

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
Time Frame: From the date of mpMRI exam (Day-1) to the date pathology report of Day 0 surgery is obtained (an average of 7 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Jochen WALZ, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPV-MRI-02-IPC 2017-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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