Clinical trial · Interventional
Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
NCT03960112CI-TRIAL-00046241NPV-MRI-02unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mpMRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mpMRI
- description
- mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
- interventionNames
- Device: mpMRI
Primary outcomes (1)
- measure
- Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
- timeFrame
- From the date of mpMRI exam (Day-1) to the date pathology report of Day 0 surgery is obtained (an average of 7 days)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDMoldovan 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
- BACKGROUNDN. 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.
- BACKGROUNDSchoots 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
- BACKGROUNDLe 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
- BACKGROUNDBranger 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
- BACKGROUNDAhmed 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.