protocolSection identificationModule nctId: NCT06281769, orgStudyIdInfo id: NL82101.000.22, briefTitle: Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, collaborators name: Angiogenesis Analytics, descriptionModule briefSummary: The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway)., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 438, type: ESTIMATED, armsInterventionsModule interventions name: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision, interventions name: MRI targeted biopsy pathway, outcomesModule primaryOutcomes measure: Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI., secondaryOutcomes measure: Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway., secondaryOutcomes measure: Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway)., secondaryOutcomes measure: Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway., secondaryOutcomes measure: Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC - location VUmc, status: RECRUITING, city: Amsterdam, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Andros Clinics, status: RECRUITING, city: Baarn, country: Netherlands, geoPoint lat: 52.21167, lon: 5.2875, locations facility: Spaarne Gasthuis, status: RECRUITING, city: Hoofddorp, country: Netherlands, geoPoint lat: 52.3025, lon: 4.68889, locations facility: St. Antonius, status: RECRUITING, city: Nieuwegein, country: Netherlands, geoPoint lat: 52.02917, lon: 5.08056, locations facility: Fransiscus Gasthuis, status: RECRUITING, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-15, uploadDate: 2024-01-12T04:56, filename: Prot_SAP_000.pdf, size: 1638356, hasResults: False