[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484041":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":50,"overallOfficials":32,"centralContacts":56,"locations":65,"responsibleParty":158,"collaborators":160,"id":164,"slug":32,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":32,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":68,"whyStopped":32,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Medical University of Bialystok","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET\u002FMR and PET\u002FCT","Validation of the diagnostic value of 68Ga-PSMA-11 (in PET \u002F CT and PET \u002F MR techniques) in the assessment stage of prostate cancer and precise assessment of the location of neoplastic changes.","24 months",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Establishing a therapeutic path depending on the PET\u002FMR and PET\u002FCT","Percentage of patients with 68Ga-PSMA-11 PET \u002F CT and 68Ga-PSMA-11 PET \u002F MR will lead to a change in the therapeutic path",{"measure":18,"description":19,"timeFrame":12},"Detection of the site of recurrence","Comparison of the frequency of detecting the site of recurrence after examination with standard methods, 68Ga-PSMA-11 PET \u002F CT and 68Ga-PSMA-11 PET \u002F MR (only for the second group)",{"measure":21,"description":22,"timeFrame":12},"Determination of PSA concentration","Determination of the PSA concentration at which the 68Ga-PSMA-11 PET \u002F MR test enables detection of local or regional recurrence (only for the second group)",{"measure":24,"description":25,"timeFrame":12},"Number of participants with adverse events related to 68Ga-PSMA-11","Serious adverse events are not expected. The radiotracer 68Ga-PSMA-11 is dose by the intravenous route in trace amounts and does not affect the patient's well-being.\n\nThe use of 68Ga-PSMA-11 is contraindicated in kidney failure and allergies to the ingredients of the preparation (all patients will have their serum creatinine measured before the test).",{"measure":27,"description":28,"timeFrame":12},"Absorbed radiation dose","Assessment and comparison of the absorbed radiation dose during the 68Ga-PSMA-11 PET \u002F CT examination and 68Ga-PSMA-11 PET \u002F MR",{"measure":30,"description":31,"timeFrame":12},"Evaluation of pharmacoeconomic data","Comparison of the costs of the procedures planned for performance after the first visit, and those that were actually made after conducting the assessed tests",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Group 1- patient of middle and high risk of prostate cancer","ACTIVE_COMPARATOR","Patients with diagnosis or high probability of prostate cancer medium and high risk according to ISUP for which implementation is planned radical treatment \\[i.e. PSA≥10 ng \u002F ml or GS ≥ 7 (ISUP ≥2) or ≥cT2b\\].",[45],"Radiation: Radiopharmaceutical 68Ga-PSMA-11 PET\u002FCT",{"label":47,"type":42,"description":48,"interventionNames":49},"Group 2- patient after radical treatment, at relapse biochemical","Prostate cancer patients after radical treatment, with recurrence biochemical tests according to the criteria of the European Society of Urology (EAU, European Association of Urology) \\[at least double measurement PSA ≥0.2 ng \u002F ml not earlier than 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) \\\u003C3 months or increase in PSA after radical radiotherapy\\> 2 ng \u002F ml above PSAnadir - the lowest PSA value found after the test treatment\\] for whom further treatment is planned and the test result imaging \u002F molecular imaging may alter the therapeutic decision",[45],[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":32},"RADIATION","Radiopharmaceutical 68Ga-PSMA-11 PET\u002FCT","The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq \u002F kg b.w.",[41,47],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":32,"email":61},"Ewa Sierko, Professor","CONTACT","85 664 67 83","ewa.sierko@iq.pl",{"name":63,"role":59,"phone":64,"phoneExt":32,"email":32},"Clinical Research Support Center Medical University of Bialystok","85 686 53 86",[66,84,93,105,116,130,144],{"facility":67,"status":68,"city":69,"state":32,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Białystok Oncology Center Maria Skłodowska-Curie","RECRUITING","Bialystok","15-027","Poland","PL",{"type":74,"coordinates":75},"Point",[76,77],23.16433,53.13333,{"lat":77,"lon":76},[80],{"name":81,"role":59,"phone":82,"phoneExt":32,"email":83},"Dorota Kazberuk, PhD","85 66 46 718","dkazberuk@onkologia.bialystok.pl",{"facility":85,"status":68,"city":69,"state":32,"zip":86,"country":71,"countryCode":72,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"University Clinical Hospital in Białystok","15-276",{"type":74,"coordinates":88},[76,77],{"lat":77,"lon":76},[91],{"name":58,"role":59,"phone":92,"phoneExt":32,"email":61},"85 831 8284",{"facility":94,"status":95,"city":69,"state":32,"zip":96,"country":71,"countryCode":72,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok","NOT_YET_RECRUITING","15-471",{"type":74,"coordinates":98},[76,77],{"lat":77,"lon":76},[101],{"name":102,"role":59,"phone":103,"phoneExt":32,"email":104},"Lech Gałek, PhD","(47) 710 40 01","lgalek@zozmswia.bialystok.pl",{"facility":106,"status":68,"city":69,"state":32,"zip":107,"country":71,"countryCode":72,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"Laboratory of Molecular Imaging and Technology Development","15-540",{"type":74,"coordinates":109},[76,77],{"lat":77,"lon":76},[112],{"name":113,"role":59,"phone":114,"phoneExt":32,"email":115},"Małgorzata Mojsak, PhD","85 500 10 20","malgorzata.mojsak@umb.edu.pl",{"facility":117,"status":68,"city":118,"state":32,"zip":119,"country":71,"countryCode":72,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz","Bydgoszcz","85-796",{"type":74,"coordinates":121},[122,123],18.00762,53.1235,{"lat":123,"lon":122},[126],{"name":127,"role":59,"phone":128,"phoneExt":32,"email":129},"Bogdan Małkowski, Professor","52-374-34-28","malkowskib@co.bydgoszcz.pl",{"facility":131,"status":95,"city":132,"state":32,"zip":133,"country":71,"countryCode":72,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź","Lodz","93-513",{"type":74,"coordinates":135},[136,137],19.47395,51.77058,{"lat":137,"lon":136},[140],{"name":141,"role":59,"phone":142,"phoneExt":32,"email":143},"Jacek Fijuth, Professor","42 689 55 55","jacekf@kopernik.lodz.pl",{"facility":145,"status":68,"city":146,"state":32,"zip":147,"country":71,"countryCode":72,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Center of Oncology of the Lublin Region St. Jana z Dukli","Lublin","20-090",{"type":74,"coordinates":149},[150,151],22.57009,51.25058,{"lat":151,"lon":150},[154],{"name":155,"role":59,"phone":156,"phoneExt":32,"email":157},"Mateusz Bilski, MD","814 541 375","bilskimat@gmail.com",{"type":159,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[161],{"name":162,"class":163},"Medical Research Agency, Poland","OTHER_GOV","100484041",false,"NCT05582876","Multicenter Assessment of Clinical Utility PET \u002F MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer","PROSPETMR2021","Inclusion Criteria:\n\nGroup 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned\n\n* Prostate adenocarcinoma confirmed by biopsy and histopathological examination\n* Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng \u002F ml) or high (Gleason score\\> 7 or cT2c or PSA\\> 20 ng \u002F ml) risk according to ISUP\n* Creatinine value allowing for safe PET \u002F MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance\\> 60 mL \u002F min\n* Age ≥18 years\n* Signing informed consent to participate in the study\n* Pelvic \u002F prostate mpMR examination performed, not earlier than 30 days before inclusion in the study\n\nGroup 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging \u002F molecular examination may affect change of therapeutic decision:\n\n* Prostate adenocarcinoma confirmed by biopsy and histopathological examination\n* After radical treatment\n* In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng \u002F ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) \\\u003C3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or\n* In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng \u002F ml\n* Age ≥18 years\n* Signing informed consent\n\nExclusion Criteria:\n\n* Presence of metallic foreign bodies \u002F implants \u002F prostheses \u002F stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination\n* Claustrophobia\n* Patient size precluding PET \u002F MR examination due to diameter gantry\n* Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)\n* Treatment for malignant neoplasm not associated with the prostate gland\n* Participating in another clinical trial\n* Lack of informed consent to participate in the study\n* Age \\\u003C18 years","MALE","18 Years","99 Years",{"count":174,"type":175},366,"ESTIMATED","INTERVENTIONAL",[178],"NA","The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET \u002F CT and PET \u002F MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment",[181],"Prostate Cancer",[183,184,185,186],"PET\u002FCT","PET\u002FMR","68Ga-PSMA-11","PSA","2025-05-05",{"date":189,"type":190},"2025-05-08","ACTUAL",{"date":192,"type":190},"2023-01-10",{"date":194,"type":175},"2026-03-31",{"name":5,"class":6},7]