Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-01 @ 6:03 AM
Study NCT ID:
NCT03960112
Status:
UNKNOWN
Last Update Posted:
2020-07-28
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081364', 'term': 'Multiparametric Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Per patient analysis in a prospective, multicenter cohort, open study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2019-05-21', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiparametric MRI', 'cystoprostatectomy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '28336078', 'type': 'BACKGROUND', '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.'}, {'type': '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.'}, {'pmid': '25511988', 'type': 'BACKGROUND', '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.'}, {'pmid': '25257029', 'type': 'BACKGROUND', '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.'}, {'pmid': '27618134', 'type': 'BACKGROUND', '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.'}, {'pmid': '28110982', 'type': 'BACKGROUND', '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.'}, {'pmid': '23312572', 'type': 'BACKGROUND', '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.'}, {'pmid': '25269630', 'type': 'BACKGROUND', '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.'}, {'pmid': '24641913', 'type': 'BACKGROUND', '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.'}, {'pmid': '18556677', 'type': 'BACKGROUND', '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.'}, {'pmid': '3203132', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference', 'detailedDescription': 'To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age \\>18 years\n2. 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)\n3. no known diagnosis of prostate cancer\n4. no contraindication to undergo multiparametric MRI\n5. Signed written informed consent prior to any screening procedures being performed\n6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen\n\nExclusion Criteria:\n\n1. allergy against MR contrast media\n2. diagnosis or previous treatment of prostate cancer\n3. severe renal insufficiency (GFR \\<30ml/min)\n4. Bladder cancer infiltrating the prostate (T4)\n5. Pelvic metallic implants such as hip prosthesis\n6. Patients scheduled for cystoprostatectomy with prostate capsule sparing\n7. Patients unable to provide informed consent\n8. Patients having a prostate biopsy \\<6 month"}, 'identificationModule': {'nctId': 'NCT03960112', 'acronym': 'NPV-MRI-02', 'briefTitle': 'Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference', 'orgStudyIdInfo': {'id': 'NPV-MRI-02-IPC 2017-047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mpMRI', 'description': 'mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen', 'interventionNames': ['Device: mpMRI']}], 'interventions': [{'name': 'mpMRI', 'type': 'DEVICE', 'description': 'mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen', 'armGroupLabels': ['mpMRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'state': 'Bouches Du Rhone', 'country': 'France', 'contacts': [{'name': 'Dominique Genre, MD', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '0033491223778'}], 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Marc COLOMBEL, Pr', 'role': 'CONTACT'}, {'name': 'Marc COLOMBEL, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13020', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'David Chemouni, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Aude Fregeville, MD', 'role': 'CONTACT'}], 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'contacts': [{'name': 'Nicolas MOTTET-AUSELO, Dr', 'role': 'CONTACT'}, {'name': 'Nicolas MOTTET-AUSELO, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Dominique GENRE, MD', 'role': 'CONTACT', 'email': 'DRCI.UP@ipc.unicancer.fr', 'phone': '33 (0)4 91 22 37 78'}, {'name': 'Margot BERLINE, MSc, MBA', 'role': 'CONTACT', 'email': 'BERLINEM@ipc.unicancer.fr', 'phone': '33 (0)4 91 22 33 14'}], 'overallOfficials': [{'name': 'Jochen WALZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}