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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03960112
• Other study ID #: NPV-MRI-02-IPC 2017-047
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2020
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 33 (0)4 91 22 37 78
• Email: DRCI.UP[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHRU Hopital Edouard Herriot	Lyon
France	Hopital Nord	Marseille
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone
France	Institut Mutualiste Montsouris	Paris
France	Chu Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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, 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. — View 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.

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. — View 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. Review. — View 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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)