[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644944":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":72,"collaborators":75,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":23,"enrollmentInfo":90,"targetDuration":23,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":107,"whyStopped":23,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SINGLE ARM UNBLINDED SINGLE SITE PILOT","EXPERIMENTAL","Study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging.Patients will undergo standard of care systemic therapy,including ADT \\& androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy.",[13,14,15,16],"Drug: Drug: 68-Ga PSMA11","Radiation: Adaptive stereotactic ablative radiotherapy (SABR)","Drug: 68Ga-PSMA-11","Radiation: Adaptive stereotactive ablative radiotherapy (SABR)",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Drug: 68-Ga PSMA11","0-3 months since initiation of ADT. Baseline PSMA PET imaging. 4-20 sites of metastasis by PSMA PET Will be injected\u002Fassessed in line with its FDA label.\n\nOther Name:",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"RADIATION","Adaptive stereotactic ablative radiotherapy (SABR)","Pre-plan 5 fraction SABR 35-40 Gy. SOC systemic therapy allows for ADT and ARSI intensification. Delivery of 3 pulses to all sites. Pulses delivered weekly.",[9],{"type":19,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"68Ga-PSMA-11","Repeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected\u002Fassessed in line with its FDA label.",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Adaptive stereotactive ablative radiotherapy (SABR)","Delivery of 2 additional pulses to all remaining PSMA PET visible sites",[9],[38],{"name":39,"affiliation":5,"role":40},"DANIEL YANG, MD","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"SARAH NEUFELD, MS, MBA","CONTACT","214 645 8525","sarah.hardee@UTSouthwestern.edu",{"name":39,"role":44,"phone":45,"phoneExt":23,"email":48},"daniel.yang@utsouthwestern.edu",[50],{"facility":5,"status":23,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Dallas","Texas","75390","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-96.80667,32.78306,{"lat":60,"lon":59},[63,67,71],{"name":64,"role":44,"phone":65,"phoneExt":23,"email":66},"SARAH NEUFELD, SUPERVISOR OF CLINICAL RESEARCH, MS, MBA","214 648 1836","Sarah.Hardee@UTSouthwestern.edu",{"name":68,"role":44,"phone":69,"phoneExt":23,"email":70},"LILIANA ROBLES","214 645 5354","LILIANA.ROBLES@UTSouthwestern.edu",{"name":39,"role":40,"phone":23,"phoneExt":23,"email":23},{"type":40,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Daniel Yang","PRINCIPAL INVESTIGATOR",[76,79],{"name":77,"class":78},"Varian, a Siemens Healthineers Company","INDUSTRY",{"name":80,"class":78},"Telix Pharmaceuticals (Innovations) Pty Ltd","100644944","early-phase-1-response-with-interim-psma-pet-in-metastatic-castration-sensitive-prostate-cancer-for-optimization-of-adaptive-metastasis-directed-radiotherapy-delivery-100644944",false,"NCT07674771","Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery","RIPCORD","Inclusion Criteria:\n\n1. History of pathologically confirmed prostate cancer.\n2. Age \\>=18 years.\n3. Performance status ECOG 0-2.\n4. Staging 68Ga PMSA-11 PET\u002FCT showing 4-20 sites of metastasis from prostate cancer within \\\u003C=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).\n5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.\n6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n7. Ability to understand and the willingness to sign a written informed consent.\n8. Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).\n\nExclusion Criteria:\n\n1. Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.\n2. Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.\n3. Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.\n4. Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.\n5. History of allergic reactions to PMSA-11 68Ga imaging agent.\n6. Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.","MALE","18 Years",{"count":91,"type":92},30,"ESTIMATED","INTERVENTIONAL",[95],"EARLY_PHASE1","The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.",[98,99,100],"Castrate Sensitive Prostate Cancer","Prostate Cancer","Metastasis Castration Resistant Prostate Cancer(mCRPC)",[102,103,104,105,106],"metastatis","poly-metastatic","prostate cancer","castration sensitive","radiotherapy","NOT_YET_RECRUITING","2026-06-24",{"date":110,"type":111},"2026-06-30","ACTUAL",{"date":113,"type":92},"2026-07-15",{"date":115,"type":92},"2029-06-15",{"name":5,"class":6},1]