[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650421":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":65,"collaborators":28,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":28,"enrollmentInfo":77,"targetDuration":28,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":96,"whyStopped":28,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-PSMA-11 PET\u002FMRI Imaging","EXPERIMENTAL","Participants will receive a single intravenous administration of gallium Ga 68 gozetotide (68Ga-PSMA-11) (111-259 MBq) followed by integrated positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) approximately 50-100 minutes after injection. PET\u002FMRI findings will be compared with multiparametric MRI alone and whole-mount histopathology following planned radical prostatectomy to evaluate the diagnostic performance of 68Ga-PSMA-11 PET\u002FMRI for selecting men with localized intermediate-risk prostate cancer for focal therapy. PET\u002FMRI results will not influence clinical management, and all participants will proceed with standard-of-care radical prostatectomy.",[13,14],"Drug: Gallium Ga 68 Gozetotide (68Ga-PSMA-11)","Diagnostic Test: Intervention Description: Integrated positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Gallium Ga 68 Gozetotide (68Ga-PSMA-11)","Intervention Description: Gallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical used for PET imaging of prostate cancer. In this study, a single intravenous dose (111-259 MBq) will be administered before PET\u002FMRI to evaluate its diagnostic performance for identifying clinically significant prostate cancer and improving selection of patients for focal therapy.",[9],[22],"Diagnostic Test",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","Intervention Description: Integrated positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions","Gallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical approved for PET imaging of PSMA-expressing lesions in men with prostate cancer. In this study, it is administered as a single intravenous injection (111-259 MBq) before PET\u002FMRI to evaluate its ability to improve detection of clinically significant intraprostatic disease and selection of patients for focal therapy compared with multiparametric MRI alone.",[9],null,[30],{"name":31,"affiliation":32,"role":33},"Adriano Basso Dias, MD, MSc, Radiologist","University Health Network - Toronto General Hospital","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Kateri Corr","CONTACT","1-416-500-5737","kateri.corr@uhn.ca",{"name":31,"role":37,"phone":41,"phoneExt":28,"email":42},"1-647-504-4609","adriano.bassodias@uhn.ca",[44],{"facility":45,"status":28,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Health Network - Princess Margaret Cancer Centre","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58,60,63],{"name":59,"role":37,"phone":41,"phoneExt":28,"email":42},"Adriano Basso Dias, MD, Radiologist",{"name":36,"role":37,"phone":61,"phoneExt":62,"email":39},"416-946-4501","5501",{"name":64,"role":33,"phone":28,"phoneExt":28,"email":28},"Adriano Basso Dias, MD",{"type":66,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100650421","68ga-psma-11-petmri-for-selecting-men-with-prostate-cancer-for-focal-therapy-100650421",false,"NCT07747493","68Ga-PSMA-11 PET\u002FMRI for Selecting Men With Prostate Cancer for Focal Therapy","The Role of 68Ga-PSMA-11 PSMA PET\u002FMRI in Selecting Patients With Prostate Cancer for Focal Therapy: A Pilot Study","PSMA-FT","Inclusion Criteria:\n\n* Ability to provide written informed consent.\n* Age 18 years or older.\n* Clinically significant prostate cancer (csPCa) with clinical stage ≤ T2c and planned radical prostatectomy.\n* Serum prostate-specific antigen (PSA) ≤ 20 ng\u002FmL.\n* Clinically significant prostate cancer within an MRI-visible lesion, defined as - International Society of Urological Pathology (ISUP) Grade Group 2 or 3 (Gleason score 3+4 or 4+3) in any biopsy core.\n\nExclusion Criteria:\n\n* Inability to lie still for the PET\u002FMRI examination.\n* Known contraindication or hypersensitivity to gallium Ga 68 gozetotide (68Ga-PSMA-11) or to the MRI gadolinium contrast agent, including any component of the formulation.","MALE","18 Years",{"count":78,"type":79},8,"ESTIMATED","INTERVENTIONAL",[82],"NA","Focal therapy is a minimally invasive treatment option for some men with localized prostate cancer. Unlike surgery or radiation, focal therapy treats only the area of the prostate containing clinically significant cancer, with the goal of preserving urinary and sexual function. Successful focal therapy depends on accurately identifying all areas of clinically significant prostate cancer before treatment. Currently, multiparametric magnetic resonance imaging (MRI) is the standard imaging method used to determine whether a patient is a suitable candidate for focal therapy. However, MRI may miss some clinically significant cancers, which can lead to incomplete treatment.\n\nThis pilot study will evaluate whether 68Ga-PSMA-11 positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) can improve the selection of men with localized prostate cancer for focal therapy compared with MRI alone. The study will enroll men with intermediate-risk prostate cancer who are already planning to undergo radical prostatectomy as part of their standard care.\n\nParticipants will receive a single injection of 68Ga-PSMA-11 followed by a PET\u002FMRI scan before surgery. The PET\u002FMRI findings and MRI findings will be reviewed separately and compared with the prostate tissue examined after surgery, which serves as the reference standard for determining the true location and extent of cancer.\n\nThe main question this study is trying to answer is whether 68Ga-PSMA-11 PET\u002FMRI is more accurate than MRI alone in identifying men who are appropriate candidates for focal therapy. The study will also evaluate whether PET\u002FMRI detects more clinically significant prostate cancer lesions than MRI alone.\n\nResearchers hypothesize that 68Ga-PSMA-11 PET\u002FMRI will improve the detection of clinically significant prostate cancer and more accurately identify patients who are suitable candidates for focal therapy, potentially reducing the risk of untreated cancer remaining in the prostate after treatment. If successful, the results of this pilot study will support the development of a larger clinical trial and may help improve future treatment planning for men with localized prostate cancer.",[85,86],"Prostate Cancer (Adenocarcinoma)","Localized Prostate Cancer",[88,89,90,91,92,86,93,94,95],"Prostate Cancer","Gallium Ga 68 Gozetotide","Positron Emission Tomography Magnetic Resonance Imaging","Multiparametric Magnetic Resonance Imaging","Focal Therapy","Intermediate-Risk Prostate Cancer","Radical Prostatectomy","Diagnostic Imaging","NOT_YET_RECRUITING","2026-07-30",{"date":99,"type":100},"2026-08-05","ACTUAL",{"date":102,"type":79},"2026-09-01",{"date":104,"type":79},"2027-12-31",{"name":5,"class":6},1]