Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-28 @ 3:30 AM
Study NCT ID:
NCT03819751
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2019-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients receive both types of biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer', 'timeFrame': 'From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit', 'description': 'Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference.'}], 'secondaryOutcomes': [{'measure': 'Analysis of the performance of software versus visual registration biopsy in subgroups', 'timeFrame': 'From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit', 'description': 'Assessment of the performance of software registration biopsy and visual registration biopsy in the detection of clinically significant cancer in :\n\n* lesions in small volume prostates (\\<50 gram) versus large volume prostates (\\>50 gram).\n* transitional zone versus peripheral zone lesions\n* basal versus apical lesions\n* small (max. diameter \\< or = 10 mm) versus large lesions (max. diameter \\> 10 mm)\n* intermediate suspicious lesions (PI-RADS 3) versus highly suspicious lesions (PI-RADS 4-5).'}, {'measure': 'Added value of systematic biopsies', 'timeFrame': 'From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit', 'description': 'Assessment of the added value of systematic biopsies on top of MRI-targeted biopsy of PI-RADS 3, 4 and 5 lesions. Compare MRI-targeted + systematic biopsies versus MRI-targeted biopsies alone in T-staging and therapy options.'}, {'measure': 'Discriminative features of PI-RADS 3 lesions on MRI', 'timeFrame': 'From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit', 'description': 'Lesion diameters, shape, intensity on T2 and aspect, ADC-values on ADC-map will be measured to identify possible discriminative features of \'malignant\' s "benigne" PI-RADS 3 lesions.'}, {'measure': 'Features of prostate cancer differentiation grade on MRI', 'timeFrame': 'From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit', 'description': 'Measure ADC-value to differentiate prostate cancer differentiation grade.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostatic neoplasms', 'biopsy', 'Multimodal Imaging', 'prostate'], 'conditions': ['Prostate Cancer', 'Prostate Neoplasm']}, 'referencesModule': {'references': [{'pmid': '27568654', 'type': 'BACKGROUND', 'citation': 'Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.'}, {'pmid': '25656808', 'type': 'BACKGROUND', 'citation': 'Futterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, Taneja SS, Thoeny H, Villeirs G, Villers A. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015 Dec;68(6):1045-53. doi: 10.1016/j.eururo.2015.01.013. Epub 2015 Feb 2.'}, {'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': '30089067', 'type': 'BACKGROUND', 'citation': 'Kasivisvanathan V, Emberton M, Moore CM. MRI-Targeted Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 Aug 9;379(6):589-590. doi: 10.1056/NEJMc1807507. No abstract available.'}, {'pmid': '22743165', 'type': 'BACKGROUND', 'citation': 'Moore CM, Robertson NL, Arsanious N, Middleton T, Villers A, Klotz L, Taneja SS, Emberton M. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol. 2013 Jan;63(1):125-40. doi: 10.1016/j.eururo.2012.06.004. Epub 2012 Jun 13.'}, {'pmid': '24298917', 'type': 'BACKGROUND', 'citation': 'Logan JK, Rais-Bahrami S, Turkbey B, Gomella A, Amalou H, Choyke PL, Wood BJ, Pinto PA. Current status of magnetic resonance imaging (MRI) and ultrasonography fusion software platforms for guidance of prostate biopsies. BJU Int. 2014 Nov;114(5):641-52. doi: 10.1111/bju.12593. Epub 2014 May 22.'}, {'pmid': '24262102', 'type': 'BACKGROUND', 'citation': 'Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8.'}, {'pmid': '23579051', 'type': 'BACKGROUND', 'citation': 'Puech P, Rouviere O, Renard-Penna R, Villers A, Devos P, Colombel M, Bitker MO, Leroy X, Mege-Lechevallier F, Comperat E, Ouzzane A, Lemaitre L. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy--prospective multicenter study. Radiology. 2013 Aug;268(2):461-9. doi: 10.1148/radiol.13121501. Epub 2013 Apr 11.'}, {'pmid': '23537686', 'type': 'BACKGROUND', 'citation': 'Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.', 'detailedDescription': "Trial Design: This is a prospective, single center, comparative, diagnostic study of two biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination) and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included. Participants receive both types of biopsy, but will be randomized concerning the order of the biopsy. All men will also receive traditional systematic biopsies. Treatment and further follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved till 2 years after initial MRI-visit.\n\nSample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy techniques, the required sample size is estimated on 96 patients.\n\nAssessment of efficacy: Efficacy of software and visual registration biopsy will be determined by histopathology: cancer core length (actual length and percentage) and comparison with systematic biopsy as reference standard.\n\nDirect access to source data and documents: The investigator(s) and the institution(s) will permit trial-related monitoring, audits, EC review, and regulatory inspections (where appropriate) by providing direct access to source data and other documents (i.e. patients' case sheets, blood test reports, X-ray reports, histology reports, etc.).\n\nData handling and management: All data collected during the study remain confidential and according to the GDPR regulation. Data of the participants will be retrieved from their electronic patient files. Each participant will be given a unique identification number. When data are coded, there continues to be a link between the data and the individual who provided it. The research team is obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. The subject's name or other identifiers should be stored separately (site file) from their research data and replaced with a unique code to create a new identity for the subject. Note that coded data are not anonymous. All data is collected and stored electronically by the principal investigator and co-investigators."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Participants need to have a prostate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willing to participate in the study by giving written informed consent.\n* male subjects aged between 50 to 75 years.\n* with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).\n* good health condition based on medical history, physical examination and vital sign measurements.\n* with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).\n\nExclusion Criteria:\n\n* has a prior history of prostate cancer.\n* had prior prostate biopsy.\n* has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).\n* has evidence of lymph nodes involvement on prostate MRI or abdominal CT\n* has evidence of bone metastasis on bone scan.\n* has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy\n* unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, …)\n* has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.'}, 'identificationModule': {'nctId': 'NCT03819751', 'acronym': 'PROSOVI', 'briefTitle': 'MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection', 'orgStudyIdInfo': {'id': 's.nr'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRI-targeted prostate biopsy', 'description': 'Participants receive both type of MRI-targeted biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.', 'interventionNames': ['Procedure: MRI-targeted prostate biopsy']}], 'interventions': [{'name': 'MRI-targeted prostate biopsy', 'type': 'PROCEDURE', 'otherNames': ['MRI/TRUS fusion biopsy with Philips Percunav'], 'description': 'All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)', 'armGroupLabels': ['MRI-targeted prostate biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Cindy Mai, MD', 'role': 'CONTACT', 'email': 'cindy.mai@uzleuven.be', 'phone': '003216345032'}, {'name': 'Hilde Vandenhout', 'role': 'CONTACT', 'email': 'hilde.vandenhout@uzleuven.be', 'phone': '003216343636'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Cindy Mai, MD', 'role': 'CONTACT', 'email': 'cindy.mai@uzleuven.be', 'phone': '016345032', 'phoneExt': '016345032'}, {'name': 'Frederik De Keyzer', 'role': 'CONTACT', 'email': 'frederik.dekeyzer@uzleuven.be', 'phone': '016347755', 'phoneExt': '016345032'}], 'overallOfficials': [{'name': 'Cindy Mai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Leuven, Department of Radiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}