[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438763":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":48,"centralContacts":71,"locations":29,"responsibleParty":80,"collaborators":82,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":29,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":132,"whyStopped":29,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":29},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Men with PI-RADS 4\u002F5 or PI-RADS 3 in conjunction with PSAD ≥ 0.15 that are randomized into arm A will undergo only targeted MRI\u002FUS fusion-guided biopsies. Men with PI-RADS 3 and PSAD \\> 0.15 with negative biopsy results will receive a follow-up MRI after 12 months. In case of upgrade to PI-RADS 4\u002F5, men will be re-biopsied. Men with PI-RADS 4\u002F5 without cancer diagnosis or with clinically insignificant cancer in the subsequent biopsy will be offered an additional MRI inbore biopsy. If MRI inbore biopsy is negative or with clinically insignificant cancer, men will be followed-up with MRI after 12 months. In the case of persistent PI-RADS 4\u002F5, men will be re-biopsied.",[13,14,15,16],"Diagnostic Test: PSA test","Device: multiparametric prostate Magnetic Resonance Imaging (mpMRI)","Procedure: targeted MRI\u002FUS fusion-guided biopsy","Procedure: MRI inbore biopsy",{"label":18,"type":19,"description":20,"interventionNames":21},"Arm B","ACTIVE_COMPARATOR","Men with PI-RADS 4\u002F5 or PI-RADS 3 in conjunction with PSAD ≥ 0.15 that are randomized into arm B will undergo targeted MRI\u002FUS fusion-guided biopsies and systematic biopsies (standard of care). Men with PI-RADS 3 and PSAD \\> 0.15 with negative biopsy results will receive a follow-up MRI after 12 months. In case of upgrade to PI-RADS 4\u002F5, men will be re-biopsied. Men with PI-RADS 4\u002F5 without cancer diagnosis or with clinically insignificant cancer in the subsequent biopsy will be offered an additional MRI inbore biopsy. If MRI inbore biopsy is negative or with clinically insignificant cancer, men will be followed-up with MRI after 12 months. In the case of persistent PI-RADS 4\u002F5, men will be re-biopsied.",[13,14,22,16],"Procedure: combined prostate biopsy (systematic biopsy plus targeted MRI\u002FUS fusion-guided biopsy)",[24,30,35,40,44],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIAGNOSTIC_TEST","PSA test","testing for blood levels of PSA",[9,18],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DEVICE","multiparametric prostate Magnetic Resonance Imaging (mpMRI)","mpMRI acquisition and reporting will be performed according to the current version of the Prostate Imaging-Reporting and Data System (PI-RADS). MpMRI will be performed at the different study centers on a 3 Tesla MR scanner using multi-phased array surface coil. MpMRI includes T1-weighted and T2-weighted imaging (T1WI, T2WI), diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE-MRI). Hyoscine butyl bromide will be administered to optimize image quality. Prostate imaging quality will be assessed by the prostate imaging quality score (PI-QUAL). In case of contraindications to MRI contrast agents, DCE will be omitted. In case of contraindications to hyoscine butyl bromide, it will be omitted. Lesions with a PI-RADS score of ≥ 4 and 3 with PSAD \\> 0.15 will considered suspicious for csPCa.",[9,18],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":29},"PROCEDURE","targeted MRI\u002FUS fusion-guided biopsy","Targeted MRI\u002FUS fusion-guided biopsy (TB) are performed using transrectal ultrasound (max. 4 cores from 3 targets). MRI\u002FUS fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.",[9],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":29},"combined prostate biopsy (systematic biopsy plus targeted MRI\u002FUS fusion-guided biopsy)","The combined biopsy comprises systematic biopsy (SB) and targeted MRI\u002FUS fusion-guided biopsy (TB). They are performed using transrectal ultrasound (number of cores: SB 12 cores, TB max. 4 cores from 3 targets). MRI\u002FUS fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.",[18],{"type":36,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"MRI inbore biopsy","MRI inbore biopsies will be offered after negative initial MRI\u002FUS fusion-guided biopsy or diagnosis of only clinically insignificant PCa in initial biopsy in arms A or B. Before performing MRI inbore biopsy the PI-RADS scoring will be re-confirmed. The number of cores will be 2 per target. In case of inaccurate needle position additional cores are allowed to ensure correct targeting. Needle position will be verified in 2 planes. Coverage with antibiotics has to be provided as per local standard of care.",[9,18],[49,53,56,59,61,63,65,68],{"name":50,"affiliation":51,"role":52},"Rouvier Al-Monajjed, MD","Heinrich Heine University Düsseldorf \u002F Urology","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":55,"role":52},"Lars Schimmöller, MD","Heinrich Heine University Düsseldorf \u002F Radiology",{"name":57,"affiliation":51,"role":58},"Peter Albers, MD","STUDY_CHAIR",{"name":60,"affiliation":55,"role":58},"Gerald Antoch, MD",{"name":62,"affiliation":55,"role":58},"Matthias Boschheidgen, MD",{"name":64,"affiliation":51,"role":58},"Jan Philipp Radtke, MD",{"name":66,"affiliation":67,"role":58},"Axel Benner","German Cancer Research Center \u002F Biostatistics",{"name":69,"affiliation":70,"role":58},"Boris Hadaschik, MD","University Hospital Essen \u002F Urology",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":29,"email":76},"Johanna Droop, PhD","CONTACT","+49 0211 81 19414","johanna.droop@med.uni-duesseldorf.de",{"name":50,"role":74,"phone":78,"phoneExt":29,"email":79},"+49 0211 81 18110","rouvier.al-monajjed@med.uni-duesseldorf.de",{"type":81,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[83,85,87,89,91,93,95,97,100,102,104],{"name":84,"class":6},"University Hospital, Aachen",{"name":86,"class":6},"University Hospital, Bonn",{"name":88,"class":6},"University Hospital of Cologne",{"name":90,"class":6},"University Hospital, Essen",{"name":92,"class":6},"University Hospital Muenster",{"name":94,"class":6},"German Cancer Research Center",{"name":96,"class":6},"Marienhospital Herne",{"name":98,"class":99},"Städtische Kliniken Mönchengladbach","UNKNOWN",{"name":101,"class":99},"Evangelische Kliniken Essen-Mitte",{"name":103,"class":99},"Klinikum Dortmund",{"name":105,"class":99},"Stiftungsklinikum PROSELIS gGmbH Recklinghausen","100438763","randomized-prospective-multi-center-cohort-study-for-primary-diagnosis-of-clinically-significant-prostate-cancer-with-combination-of-psadre-and-multi-parametric-magnetic-resonance-imaging-100438763",false,"NCT04993508","Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer With Combination of PSA\u002FDRE and Multi Parametric Magnetic Resonance Imaging","PRIMA","Inclusion Criteria:\n\n* Men aged from 50 to 75 years\n* elevated PSA ≥ 3 ng\u002Fml and\u002For cancer suspicious DRE\n\nExclusion Criteria:\n\n* Men with known prostate cancer\n* men with prior prostate biopsy\n* men with non-MRI compatible devices\n* men with acute prostatitis","MALE","50 Years","75 Years",{"count":117,"type":118},1908,"ESTIMATED","INTERVENTIONAL",[121],"NA","This randomized prospective multi center study is designed to confirm a new diagnostic pathway in primary diagnosis of clinically significant prostate cancer by combination of serum levels of prostate specific antigen (PSA), digitorectal examination (DRE), and multiparametric magnetic resonance imaging (mpMRI). Men at the age of 50 to 75 with an elevated PSA (\\>= 3 ng\u002Fml) and \u002For suspicious DRE receive an upfront multi parametric MRI. Only men with MRI results suspicious of clinically significant prostate cancer will be biopsied. Those will be randomized into arm A and arm B. Arm A undergoes only targeted MRI\u002FUS fusion-guided biopsies (= TB with a maximum of 3 targets and 4 cores per target). Arm B receives systematic biopsies (= SB with 12 biopsy cores) and TB. Men with unsuspicious mpMRI will be receive follow-up according to current clinical standards. PRIMA will prospectively evaluate if stand-alone targeted MRI\u002FUS fusion-guided biopsy alone is sufficient to detect clinically significant prostate cancer (csPC with (ISUP grade group ≥ 2) and to avoid unnecessary detection of low-grade PC (ISUP 1) in biopsy-naïve men compared to a combined biopsy (systematic plus targeted) approach. The results of this study will directly influence clinical practice, will have a positive impact on patients' lives, and will lower the financial burden due to reduced overdiagnosis and over treatment.",[124],"Prostate Cancer",[126,127,128,129,130,131],"prostate cancer","prostate cancer diagnosis","multiparametric Magnetic Resonance Imaging (mpMRI)","detection of clinically significant prostate cancer","avoidance of over diagnosis","PSA","NOT_YET_RECRUITING","2025-09-23",{"date":135,"type":136},"2025-09-26","ACTUAL",{"date":138,"type":118},"2026-04-01",{"date":140,"type":118},"2030-03-31",{"name":5,"class":6}]