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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)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mpMRI
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring multiparametric MRI, cystoprostatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Institut Paoli Calmettes
  • CHRU Hopital Edouard Herriot
  • Hopital Nord
  • Institut Mutualiste Montsouris
  • Chu Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mpMRI

Arm Description

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

Outcomes

Primary Outcome Measures

Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
July 27, 2020
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT03960112
Brief Title
Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
Acronym
NPV-MRI-02
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
multiparametric MRI, cystoprostatectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Per patient analysis in a prospective, multicenter cohort, open study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mpMRI
Arm Type
Experimental
Arm Description
mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
Intervention Type
Device
Intervention Name(s)
mpMRI
Intervention Description
mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
Primary Outcome Measure Information:
Title
Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
Description
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.
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)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age >18 years 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) no known diagnosis of prostate cancer no contraindication to undergo multiparametric MRI Signed written informed consent prior to any screening procedures being performed Patient affiliated to the ''National security'' regimen or beneficiary of this regimen Exclusion Criteria: allergy against MR contrast media diagnosis or previous treatment of prostate cancer severe renal insufficiency (GFR <30ml/min) Bladder cancer infiltrating the prostate (T4) Pelvic metallic implants such as hip prosthesis Patients scheduled for cystoprostatectomy with prostate capsule sparing Patients unable to provide informed consent Patients having a prostate biopsy <6 month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
33 (0)4 91 22 37 78
Email
DRCI.UP@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Margot BERLINE, MSc, MBA
Phone
33 (0)4 91 22 33 14
Email
BERLINEM@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen WALZ, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
State/Province
Bouches Du Rhone
ZIP/Postal Code
13009
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Genre, MD
Phone
0033491223778
Email
drci.up@ipc.unicancer.fr
Facility Name
CHRU Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc COLOMBEL, Pr
First Name & Middle Initial & Last Name & Degree
Marc COLOMBEL, Pr
Facility Name
Hopital Nord
City
Marseille
ZIP/Postal Code
13020
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Chemouni, MD
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude Fregeville, MD
Facility Name
Chu Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MOTTET-AUSELO, Dr
First Name & Middle Initial & Last Name & Degree
Nicolas MOTTET-AUSELO, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28336078
Citation
Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25511988
Citation
Schoots IG, Petrides N, Giganti F, Bokhorst LP, Rannikko A, Klotz L, Villers A, Hugosson J, Moore CM. Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. Eur Urol. 2015 Apr;67(4):627-36. doi: 10.1016/j.eururo.2014.10.050. Epub 2014 Nov 15.
Results Reference
background
PubMed Identifier
25257029
Citation
Le JD, Tan N, Shkolyar E, Lu DY, Kwan L, Marks LS, Huang J, Margolis DJ, Raman SS, Reiter RE. Multifocality and prostate cancer detection by multiparametric magnetic resonance imaging: correlation with whole-mount histopathology. Eur Urol. 2015 Mar;67(3):569-76. doi: 10.1016/j.eururo.2014.08.079. Epub 2014 Sep 23.
Results Reference
background
PubMed Identifier
27618134
Citation
Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.
Results Reference
background
PubMed Identifier
28110982
Citation
Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
Results Reference
background
PubMed Identifier
23312572
Citation
Robertson NL, Hu Y, Ahmed HU, Freeman A, Barratt D, Emberton M. Prostate cancer risk inflation as a consequence of image-targeted biopsy of the prostate: a computer simulation study. Eur Urol. 2014 Mar;65(3):628-34. doi: 10.1016/j.eururo.2012.12.057. Epub 2013 Jan 3.
Results Reference
background
PubMed Identifier
25269630
Citation
Wetterauer C, Weibel M, Gsponer JR, Vlajnic T, Zellweger T, Butikofer S, Muller G, Puschel H, Bachmann A, Gasser TC, Bubendorf L, Rentsch CA. Incidental prostate cancer prevalence at radical cystoprostatectomy--importance of the histopathological work-up. Virchows Arch. 2014 Dec;465(6):629-36. doi: 10.1007/s00428-014-1656-9. Epub 2014 Oct 1.
Results Reference
background
PubMed Identifier
24641913
Citation
Bains LJ, Studer UE, Froehlich JM, Giannarini G, Triantafyllou M, Fleischmann A, Thoeny HC. Diffusion-weighted magnetic resonance imaging detects significant prostate cancer with high probability. J Urol. 2014 Sep;192(3):737-42. doi: 10.1016/j.juro.2014.03.039. Epub 2014 Mar 15.
Results Reference
background
PubMed Identifier
18556677
Citation
Steinberg DM, Fine J, Chappell R. Sample size for positive and negative predictive value in diagnostic research using case-control designs. Biostatistics. 2009 Jan;10(1):94-105. doi: 10.1093/biostatistics/kxn018. Epub 2008 Jun 12.
Results Reference
background
PubMed Identifier
3203132
Citation
DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.
Results Reference
background

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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

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