[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585371":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":45,"locations":51,"responsibleParty":68,"collaborators":36,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":36,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":36,"enrollmentInfo":79,"targetDuration":36,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":94,"whyStopped":36,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"PET+\u002FmpMRI+ group","EXPERIMENTAL","Patients in this group will undergo 68Ga-PSMA PET\u002FmpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET\u002FCT.",[13],"Diagnostic Test: Prostate biopsy guided by PSMA PET\u002FCT",{"label":15,"type":10,"description":16,"interventionNames":17},"PET+\u002FmpMRI- group","Patients in this group will undergo 68Ga-PSMA PET\u002FmpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET\u002FCT.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"PET-\u002FmpMRI+ group","ACTIVE_COMPARATOR","Patients in this group will undergo 68Ga-PSMA PET\u002FmpMRI imaging, and the results show negative findings on PSMA PET and positive on mpMRI. These patients will undergo prostate biopsy guided by mpMRI and US.",[23],"Diagnostic Test: Prostate biopsy guided by mpMRI\u002FUS",{"label":25,"type":26,"description":27,"interventionNames":28},"PET-\u002FmpMRI- group","PLACEBO_COMPARATOR","Patients in this group will undergo 68Ga-PSMA PET\u002FmpMRI imaging, and the results show negative findings on both PSMA PET and mpMRI. These patients will undergo systematic prostate biopsy.",[29],"Diagnostic Test: Systematic prostate biopsy",[31,37,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DIAGNOSTIC_TEST","Prostate biopsy guided by PSMA PET\u002FCT","The patient will undergo pelvic non-contrast CT imaging. After co-registration of the CT images with 68Ga-PSMA PET\u002FCT data at corresponding anatomical levels, a percutaneous gluteal approach will be utilized for CT-guided prostate biopsy.",[9,15],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Prostate biopsy guided by mpMRI\u002FUS","The patient will undergo transrectal ultrasound (TRUS) prostate scanning. After co-registration and precise image fusion of TRUS findings with multiparametric MRI (mpMRI) data, a transperineal percutaneous approach will be employed to perform TRUS-guided prostate biopsy.",[19],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Systematic prostate biopsy","The patient will undergo systematic prostate biopsy under TRUS guidance.",[25],[46],{"name":47,"role":48,"phone":49,"phoneExt":36,"email":50},"Hongbin Sun Sun, MD, PHD","CONTACT","+86-02552271061","docshb@126.com",[52],{"facility":53,"status":36,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Nanjing First Hospital","Nanjing","Jiangsu","210006","China","CN",{"type":60,"coordinates":61},"Point",[62,63],118.77778,32.06167,{"lat":63,"lon":62},[66],{"name":67,"role":48,"phone":49,"phoneExt":36,"email":50},"Hongbin Sun, MD, PHD",{"type":69,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100585371","the-diagnostic-application-of-psmapetmr-in-patients-undergoing-secondary-prostate-puncture-100585371",false,"NCT06901492","The Diagnostic Application of PSMAPET\u002FMR in Patients Undergoing Secondary Prostate Puncture","The Diagnostic Application of PSMA PET\u002FMR in Patients with PSA \u003C20 Ng\u002Fml and Initial Negative Prostate Biopsy","Inclusion Criteria:\n\n1. Age ≥40 years, male;\n2. Serum PSA level 4-20 ng\u002FmL;\n3. Serum PSA level 4-20 ng\u002FmL;\n4. No contraindications to PSMA-PET\u002FCT or MRI;\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. Serum PSA \\>20 ng\u002FmL;\n2. History of prostate surgery\u002Fradiotherapy;\n3. Acute prostatitis;\n4. Coagulation disorders or active infection;\n5. Severe internal\u002Fexternal hemorrhoids, perianal, rectal, or gluteal lesions;\n6. Allergy to local anesthetics;\n7. Inability to tolerate the biopsy procedure.","MALE","40 Years",{"count":80,"type":81},120,"ESTIMATED","INTERVENTIONAL",[84],"NA","The present study is designed to explore the value of targeted puncture guided by PSMA PET\u002FCT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy",[87,88,89],"PSMA PET\u002FCT","Prostate Cancer","MpMRI",[91,87,92,93],"Prostate cancer","mpMRI","Prostate biopsy","NOT_YET_RECRUITING","2025-03-23",{"date":97,"type":98},"2025-03-30","ACTUAL",{"date":100,"type":81},"2025-06-01",{"date":102,"type":81},"2028-06-01",{"name":5,"class":6},1]