[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559524":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":68,"collaborators":70,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":21,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":21,"enrollmentInfo":86,"targetDuration":21,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":21,"overallStatus":42,"whyStopped":21,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Region Västerbotten","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET\u002FmpMRI or mpMRI","EXPERIMENTAL","One-time pre-surgical imaging using \\[18F\\]PSMA-PET\u002FmpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)",[13,14],"Drug: [18F]PSMA-PET","Device: MRI sequences optimized for prostate cancer examinations",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","[18F]PSMA-PET","Pre-surgical imaging using \\[18F\\]PSMA-PET at Umea University Hospital, 3.5 MBq\u002Fkg, i.v. injection.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DEVICE","MRI sequences optimized for prostate cancer examinations","T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital",[9],[28],{"name":29,"affiliation":5,"role":30},"Camilla Thellenberg Karlsson, MD, PhD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","+46907850000","camilla.thellenberg@umu.se",{"name":37,"role":33,"phone":34,"phoneExt":21,"email":38},"Tufve Nyholm, PhD","tufve.nyholm@umu.se",[40,57],{"facility":41,"status":42,"city":43,"state":21,"zip":21,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Region Skåne","RECRUITING","Malmö","Sweden","SE",{"type":47,"coordinates":48},"Point",[49,50],13.00073,55.60587,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":55,"phoneExt":21,"email":56},"Adalsteinn Gunnlaugsson, MD, PhD","+46 46 17 10 00","adalsteinn.gunnlaugsson@skane.se",{"facility":5,"status":42,"city":58,"state":21,"zip":21,"country":44,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Umeå",{"type":47,"coordinates":60},[61,62],20.25972,63.82842,{"lat":62,"lon":61},[65],{"name":66,"role":33,"phone":67,"phoneExt":21,"email":35},"Camilla Thellenberg Karlsson","+46 907850000",{"type":69,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[71,74,76],{"name":72,"class":73},"Umeå University","OTHER",{"name":75,"class":73},"Region Skane",{"name":77,"class":73},"Lund University","100559524","phase-3-evaluation-of-psma-pet-and-mpmri-in-high-risk-prostate-cancer---using-histopathologic-validation-100559524",false,"NCT06565247","Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation","Inclusion Criteria:\n\n1. Histologically confirmed prostate cancer planned to be treated with radical prostatectomy\n2. PSMA-PET\u002FCT conducted as part of the clinical management for the existing prostate cancer.\n3. ≥4 weeks since last biopsy of the prostate\n4. One or more of the following criteria\n\n   1. cT3, or high suspicion of extra prostatic growth on mpMRI\n   2. Gleason score ≥8\n   3. PSA 20-49 ng\u002Fml\n5. \\>18 years\n6. Given a written consent to participate in the trial\n\nExclusion Criteria:\n\n1. Non-MR-safe implants or another contraindication to MRI or PET\n2. Claustrophobia\n3. Unfit for MRI or PET\u002FMRI examination for any other reason, e.g., back pain\n4. WHO PS \\>1\n5. Patients treated with neoadjuvant\u002Fconcomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)\n6. TUR-P within 6 months\n7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.\n8. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.\n9. Creatinine clearance \\\u003C 30ml\u002Fmin (acc. to http:\u002F\u002Fwww.fass.se\u002FLIF\u002Fproduktfakta-\u002Fkreatinin.jsp)\n10. Tinnitus or severe hearing loss","MALE","18 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"PHASE3","In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.",[94],"Prostate Cancer","2025-03-03",{"date":97,"type":98},"2025-03-04","ACTUAL",{"date":100,"type":98},"2024-10-14",{"date":102,"type":88},"2031-12",{"name":5,"class":6},2]