[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560650":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":39,"overallOfficials":17,"centralContacts":17,"locations":49,"responsibleParty":70,"collaborators":17,"id":74,"slug":17,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":73,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":17,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":52,"whyStopped":17,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Salzburger Landeskliniken","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Detection of Clinically Significant Prostate Cancer via Prostate Biopsy","This measure assesses whether participants have clinically significant prostate cancer (Gleason Score Sum ≥ ISUP 2) based on biopsy results, recorded as \"yes\" or \"no\".","2 Weeks",[14],{"measure":15,"description":16,"timeFrame":12},"Detection of Clinically Insignificant Prostate Cancer via Prostate Biopsy","This measure evaluates whether participants have clinically insignificant prostate cancer (Gleason Score Sum = ISUP 1) based on biopsy results, also recorded as \"yes\" or \"no\".",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Participants are randomly divided into two groups. One group (the experimental group) receives the combination of high-frequency micro-ultrasound, multiparametric MRI-targeted biopsy, and systematic biopsy. The other group (the control group) receives the current standard care, which includes only multiparametric MRI-targeted biopsy and systematic biopsy. This setup allows direct comparison of the detection rates of clinically significant prostate cancer between the new combination of interventions and the standard approach.","DIAGNOSTIC",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","The primary objective of this study is (i) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy detects more clinically significant prostate cancer (\\>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).\n\nThe secondary objective of this study is (ii) to demonstrate that the combination of high frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy, and systematic biopsy does not detect more clinically insignificant prostate cancer (ISUP 1) than multiparametric MRI target biopsy and systematic biopsy alone (current standard of care).\n\nThe third objective of this study is (iii) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy does not detect less clinically significant prostate cancer (\\>= ISUP 2) than multiparametric MRI target biopsy and systematic biopsy (current standard of care).\n\nThe fourth objective of this study is (iv) to demonstrate that the combination of highfrequency micro-ultrasound target biopsy and multiparametric MRI target biopsy detects less clinically insignificant prostate cancer (ISUP 1) than the combination of multiparametric MRI target biopsy and systematic biopsy (current standard of care).",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Group U","EXPERIMENTAL","Use of high-frequency micro-ultrasound target biopsy, multiparametric MRI target biopsy and systematic biopsy for tumor detection",[32],"Device: High-frequency micro-ultrasound target biopsy",{"label":34,"type":35,"description":36,"interventionNames":37},"Group S","ACTIVE_COMPARATOR","Use of multiparametric MRI target biopsy and systematic biopsy (current standard of care) for tumor detection",[38],"Device: conventional Multiparametric MRT target biopsy",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":17},"DEVICE","High-frequency micro-ultrasound target biopsy","1. High-frequency micro-ultrasound (transrectal ultrasound, 29 Hz, ExactVu) of the prostate. If suspicious lesions (PRIMUS \\>= 3) other than those already detected in multiparametric MRI are found, target biopsy will be performed. Maximum of four cores per lesion.\n2. Multiparametric MRI target biopsy (PI-RADS \\>= 3) of the prostate (transrectal ultrasound, 29 Hz, ExactVu). Maximum of four cores per lesion.\n3. Systematic biopsy (twelve cores) of the prostate",[28],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":17},"conventional Multiparametric MRT target biopsy","1. Multiparametric MRT target biopsy (PI-RADS \\>= 3) of the prostate (conventional transrectal ultrasound, 8-10 Hz). Maximum of four cores per lesion.\n2. Systematic biopsy (twelve cores) of the prostate",[34],[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Uniklinikum Salzburg, Department for Urology and Andrology","RECRUITING","Salzburg","State of Salzburg","5020","Austria","AT",{"type":59,"coordinates":60},"Point",[61,62],13.04399,47.79941,{"lat":62,"lon":61},[65],{"name":66,"role":67,"phone":68,"phoneExt":17,"email":69},"Lukas Lusuardi, Univ.Prof.Dr.","CONTACT","0043 57255 27402","l.lusuardi@salk.at",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Maximilian Pallauf","Biopsy29","100560650",false,"NCT06579911","Combining High-frequency Micro-ultrasound and Multiparametric MRI Target Biopsy for Detecting Prostate Cancer","Combining High-frequency Micro-ultrasound Target Biopsy and Multiparametric MRI Target Biopsy - Does it Increase the Detection Rate of Clinically Significant Prostate Cancer? A Prospective, Interventional, Single Centre, Randomized Controlled Trial","Inclusion Criteria:\n\n\\- Men with suspected clinically significant prostate cancer, identified by the rise in PSA level, suspicious digital rectal examination or both and pathologic multiparametric MRI of the prostate (\\>= PI-RADS III)\n\nExclusion Criteria:\n\n* Patients with histopathologic proven prostate cancer\n* PSA \\> 20 ng\u002Fml\n* Finding in digital rectal examination \\>= cT2c\n* Untreated bacterial infection of the prostate\n* Untreated coagulopathy",true,"MALE","18 Years","99 Years",{"count":85,"type":86},400,"ESTIMATED","INTERVENTIONAL",[89],"NA","\\*\\*Study Goal:\\*\\* The purpose of this clinical trial is to determine if combining high-frequency micro-ultrasound with multiparametric MRI biopsy and a systematic biopsy can better detect clinically significant prostate cancer compared to current standard methods. This study is aimed at men who may have prostate cancer.\n\n\\*\\*Main Questions the Study Aims to Answer:\\*\\*\n\n1. Does the combination of new biopsy methods detect more clinically significant prostate cancers than the current standard method?\n2. Does the new method not increase the detection of less serious forms of cancer beyond what the standard method detects?\n\n\\*\\*Participation in the Study:\\*\\*\n\nParticipants in this study will undergo the following procedures:\n\n* A high-frequency micro-ultrasound examination of the prostate.\n* A multiparametric MRI-targeted biopsy of the prostate.\n* A systematic biopsy of the prostate.\n\n\\*\\*Comparison Group:\\*\\* Researchers will compare the new combination method with the current standard method to see if the new approach is more effective.\n\n\\*\\*Participants will:\\*\\*\n\n* Undergo several exams and biopsies depending on the results of previous tests.\n* Attend regular follow-up appointments to monitor potential side effects and evaluate prostate health.\n* Record their experiences and any symptoms in a diary.",[92],"Prostatic Neoplasm of Uncertain Behavior",[94,95,96,97,98,99,100],"Prostate cancer","prostate biopsy","high frequency ultrasound","fusion biopsy","multiparametric mri of prostate","pirads","primus","2026-06-05",{"date":103,"type":104},"2026-06-09","ACTUAL",{"date":106,"type":104},"2023-11-01",{"date":108,"type":86},"2028-01-01",{"name":5,"class":6},1]