[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533005":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":54,"collaborators":22,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":22,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":22,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":35,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biochemical recurrent prostate cancer but not radio-morphological local recurrence","EXPERIMENTAL","Patients with prostate cancer and confirmed biochemical recurrence with PSA of ≥ 0.2 ng\u002Fml after radical prostatectomy or PSA \\> nadir + 2ng\u002Fml after radiotherapy but not radio-morphological local recurrence after primary therapy with curative intent will receive systemic therapy with \\[177Lu\\]Lu-PSMAI\\&T radioligand therapy",[13],"Drug: [177Lu]Lu-PSMA I&T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[177Lu]Lu-PSMA I&T","2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of \\[177Lu\\]Lu-PSMAI\\&T radioligand therapy at 6-week intervals",[9],[21],"PSMA-RLT",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Sazan Rasul, PhD","CONTACT","004314040058742","sazan.rasul@meduniwien.ac.at",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":32},"Shahrokh F. Shariat, Professor","004314040026150","shahrokh.shariat@meduniwien.ac.at",[34],{"facility":5,"status":35,"city":36,"state":22,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Vienna","1090","Austria","AT",{"type":41,"coordinates":42},"Point",[43,44],16.37208,48.20849,{"lat":44,"lon":43},[47,49,51],{"name":25,"role":26,"phone":48,"phoneExt":22,"email":28},"014040058742",{"name":25,"role":50,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"name":52,"role":53,"phone":22,"phoneExt":22,"email":22},"Pawel Rajwa, MD","SUB_INVESTIGATOR",{"type":50,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Sazan Rasul, MD, PhD","Physician and post-doctoral researcher","100533005","phase-2-psma-rlt-in-biochemically-recurrent-pca-100533005",false,"NCT06220188","PSMA-RLT in Biochemically Recurrent PCa","[177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study","Inclusion Criteria:\n\n* Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.\n* No hormonal therapy within the last 12 months or recovered testosterone levels.\n* PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0\u002FcM1).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 \u002FL, Platelets ≥100 x 109 \u002FL and Haemoglobin ≥9 g\u002FdL.\n* Patients must have adequate renal function with eGFR ≥ 50mL\u002Fmin\u002F1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g\u002FdL.\n* Patients must be able to sign Informed Consent Form.\n\nExclusion Criteria:\n\n* Concomitant participation in any other interventional trial.\n* Concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year.\n* Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.\n* Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.","MALE","18 Years","80 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng\u002Fml after radical prostatectomy (RP) or PSA \\> nadir + 2ng\u002Fml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.",[75],"Prostate Cancer Recurrent",[17,77,78,79,80],"PSMA-radioligand therapy","Biochemical recurrence","Prostate cancer","PSA value","2024-02-10",{"date":83,"type":84},"2024-02-13","ACTUAL",{"date":86,"type":84},"2024-01-15",{"date":88,"type":69},"2027-01",{"name":5,"class":6},1]