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

NCT03960112 | Unknown

• 1 other identifier: NPV-MRI-02-IPC 2017-047
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Prostate Cancer

Keywords

multiparametric MRI; cystoprostatectomy

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

mpMRI

EXPERIMENTAL

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

Device: mpMRI

Interventions

mpMRI DEVICE

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

mpMRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (5)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Location

CHRU Hopital Edouard Herriot

Lyon, 69437, France

Location

Hopital Nord

Marseille, 13020, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (11)

• 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.

  PMID: 28336078 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25511988 BACKGROUND

• 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.

  PMID: 25257029 BACKGROUND

• 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.

  PMID: 27618134 BACKGROUND

• 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.

  PMID: 28110982 BACKGROUND

• 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.

  PMID: 23312572 BACKGROUND

• 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.

  PMID: 25269630 BACKGROUND

• 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.

  PMID: 24641913 BACKGROUND

• 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.

  PMID: 18556677 BACKGROUND

• 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.

  PMID: 3203132 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jochen WALZ, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Per patient analysis in a prospective, multicenter cohort, open study.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: May 22, 2019
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)