[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516364":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":95,"collaborators":18,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":18,"enrollmentInfo":107,"targetDuration":18,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PSMA PET","EXPERIMENTAL","These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will be randomized to undergo a single \\[18\\]F-PSMA-1007 PET\u002FCT or PET\u002FMRI scan prior to focal therapy. If they are diagnosed with bilateral disease, they will be ineligible for focal therapy and be referred for radical therapy. Those with unilateral disease will then proceed to focal therapy. They will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation\n\nIntravenous bolus injection of 4 MBq\u002Fkg +\u002F- 10% of \\[18\\]F-PSMA-1007, up to a maximum of 400 MBq.",[13],"Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scan",{"label":15,"type":16,"description":17,"interventionNames":18},"No Additional Imaging","NO_INTERVENTION","These patients will have been diagnosed with unilateral prostate cancer by standard of care diagnostic tests deemed eligible and interested in focal therapy. These patients will undergo no further testing and will undergo focal therapy.\n\nThey will then receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation.\n\nIntravenous bolus injection of 4 MBq\u002Fkg +\u002F- 10% of \\[18\\]F-PSMA-1007, up to a maximum of 400 MBq.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIAGNOSTIC_TEST","PSMA-1007 Positron Emission Tomography (PET) scan","Additional staging PET scan prior to focal therapy to focal therapy.",[9],[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Adam Kinnaird, MD, PhD","CONTACT","(780) 407-5800","321","ask@ualberta.ca",{"name":33,"role":28,"phone":18,"phoneExt":18,"email":34},"Alexander Tamm, MD","astamm@ualberta.ca",[36,57,69,77],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Prostate Cancer Centre","RECRUITING","Calgary","Alberta","T2V 1P9","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-114.08529,51.05011,{"lat":48,"lon":47},[51,54],{"name":52,"role":28,"phone":18,"phoneExt":18,"email":53},"Arjuni Seevaratnam","Arjuni.s@prostatecancercentre.ca",{"name":55,"role":56,"phone":18,"phoneExt":18,"email":18},"Bimal Bhindi, MD","PRINCIPAL_INVESTIGATOR",{"facility":58,"status":38,"city":59,"state":40,"zip":60,"country":42,"countryCode":43,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Royal Alexandra Hospital","Edmonton","T5H 3V9",{"type":45,"coordinates":62},[63,64],-113.46871,53.55014,{"lat":64,"lon":63},[67],{"name":33,"role":28,"phone":68,"phoneExt":18,"email":34},"780-407-6810",{"facility":70,"status":38,"city":59,"state":40,"zip":71,"country":42,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"University of Alberta Hospital","T6G 2B7",{"type":45,"coordinates":73},[63,64],{"lat":64,"lon":63},[76],{"name":33,"role":28,"phone":68,"phoneExt":18,"email":34},{"facility":78,"status":38,"city":79,"state":80,"zip":81,"country":42,"countryCode":43,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Princess Margaret Cancer Centre","Toronto","Ontario","M5G 2M9",{"type":45,"coordinates":83},[84,85],-79.39864,43.70643,{"lat":85,"lon":84},[88,93],{"name":89,"role":28,"phone":90,"phoneExt":91,"email":92},"Jenna Hiemstra","416-946-4501","3381","Jenna.Hiemstra2@uhn.ca",{"name":94,"role":56,"phone":18,"phoneExt":18,"email":18},"Nathan Perlis, MD",{"type":96,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100516364","phase-2-psma-guided-ablation-of-the-prostate-100516364",false,"NCT06003556","PSMA-Guided Ablation of the Prostate","PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial","P-GAP","Inclusion Criteria:\n\n1. Age \\> 50\n2. Clinical stage \\\u003C T2b\n3. PSA \\\u003C 15\n4. Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer\n\nExclusion Criteria:\n\n1. Unable to obtain consent\n2. Weight \\>250 kg (weight limitation of scanners)\n3. Unable to lie flat for 30 minutes to complete the PET imaging\n4. Lack of intravenous access\n5. eGFR \\\u003C 40 mL\u002Fmin\u002F1.73 m2 and\u002For a history of a severe reaction to CT contrast\n6. Prior androgen deprivation therapy or radiation therapy to prostate gland","MALE","50 Years",{"count":108,"type":109},138,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007) compared to standard of care multiparametric MRI and MRI targeted-prostate biopsy for staging in patients diagnosed with unilateral prostate cancer who are eligible for focal therapy.\n\nThe main question it aims to answer is:\n\nCan PSMA PET improve diagnostic accuracy for the primary staging of Prostate Cancer for patients undergoing focal therapy thereby reducing residual and recurrence disease?\n\nParticipants who are eligible by current standard of care diagnostic workup will undergo 1:1 randomization to PSMA PET scan or no further imaging. Those diagnosed with bilateral disease by PSMA PET will be ineligible for focal therapy and be referred for radical therapy. Men with unilateral disease on PSMA PET and those randomized to no further imaging will then undergo focal therapy. All men undergoing focal therapy will receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. The primary outcome will be the detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after hemigland ablation.",[115,116],"Prostate Cancer","Localized Prostate Carcinoma",[115,118,119,120],"PSMA Pet","Focal Therapy","Localized Prostate Cancer","2026-06-02",{"date":123,"type":124},"2026-06-03","ACTUAL",{"date":126,"type":124},"2024-04-02",{"date":128,"type":109},"2029-02-26",{"name":5,"class":6},4]