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出境医 / 临床实验 / 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)

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)

Study Description
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
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
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, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for location information
France
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, France, 13009
Contact: Dominique Genre, MD    0033491223778    drci.up@ipc.unicancer.fr   
CHRU Hopital Edouard Herriot
Lyon, France, 69437
Contact: Marc COLOMBEL, Pr         
Principal Investigator: Marc COLOMBEL, Pr         
Hopital Nord
Marseille, France, 13020
Contact: David Chemouni, MD         
Institut Mutualiste Montsouris
Paris, France, 75014
Contact: Aude Fregeville, MD         
Chu Saint Etienne
Saint Etienne, France, 42055
Contact: Nicolas MOTTET-AUSELO, Dr         
Principal Investigator: Nicolas MOTTET-AUSELO, Dr         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Layout table for investigator information
Principal Investigator: Jochen WALZ, MD Institut Paoli-Calmettes
Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date July 28, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
Official Title  ICMJE Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Device: mpMRI
mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
Study Arms  ICMJE Experimental: mpMRI
mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
Intervention: Device: mpMRI
Publications *
  • 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, Rouvière 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. Review.
  • 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.
  • 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. Review.
  • 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.
  • 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.
  • 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.
  • 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.
  • Wetterauer C, Weibel M, Gsponer JR, Vlajnic T, Zellweger T, Bütikofer S, Müller G, Püschel 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960112
Other Study ID Numbers  ICMJE NPV-MRI-02-IPC 2017-047
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jochen WALZ, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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