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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 (NPV-MRI-02)

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ClinicalTrials.gov Identifier: NCT03960112
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: mpMRI Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Per patient analysis in a prospective, multicenter cohort, open study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960112


Contacts
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Contact: Dominique GENRE, MD 33 (0)4 91 22 37 78 DRCI.UP@ipc.unicancer.fr
Contact: Margot BERLINE, MSc, MBA 33 (0)4 91 22 33 14 BERLINEM@ipc.unicancer.fr

Locations
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France
Institut Paoli Calmettes Not yet recruiting
Marseille, Bouches Du Rhone, France, 13009
Contact: Dominique Genre, MD    0033491223778    drci.up@ipc.unicancer.fr   
CHRU Hopital Edouard Herriot Not yet recruiting
Lyon, France, 69437
Contact: Marc COLOMBEL, Pr         
Principal Investigator: Marc COLOMBEL, Pr         
Hopital Nord Not yet recruiting
Marseille, France, 13020
Contact: David Chemouni, MD         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France, 75014
Contact: Aude Fregeville, MD         
Chu Saint Etienne Not yet recruiting
Saint Etienne, France, 42055
Contact: Nicolas MOTTET-AUSELO, Dr         
Principal Investigator: Nicolas MOTTET-AUSELO, Dr         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Jochen WALZ, MD Institut Paoli-Calmettes

Publications:
N. Mottet JB, E. Briers, R.C.N. van den Bergh, M. Bolla, N.J. van Casteren, P. Cornford, S. Culine, S. Joniau, T. Lam, M.D. Mason, V. Matveev, H. van der Poel, T.H. van der Kwast, O. Rouvière, T. Wiegel. Guidelines on prostate cancer. European Association of Urology Web site https://uroweborg/guideline/prostate-cancer/. Accessed May 17, 2016.

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03960112     History of Changes
Other Study ID Numbers: NPV-MRI-02-IPC 2017-047
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
multiparametric MRI
cystoprostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases