[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531862":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":101,"centralContacts":105,"locations":111,"responsibleParty":197,"collaborators":83,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":83,"eligibilityCriteria":205,"healthyVolunteers":201,"sex":206,"minAge":207,"maxAge":83,"enrollmentInfo":208,"targetDuration":83,"studyType":211,"phases":212,"briefSummary":214,"conditions":215,"keywords":83,"overallStatus":114,"whyStopped":83,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group I (SBRT)","EXPERIMENTAL","Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.",[13,14,15,16,17,18],"Drug: Antiandrogen Therapy","Procedure: Biospecimen Collection","Procedure: Positron Emission Tomography","Radiation: Stereotactic Body Radiation Therapy","Other: Survey Administration","Procedure: Magnetic Resonance Imaging",{"label":20,"type":10,"description":21,"interventionNames":22},"Group II (Hypofractionated radiation therapy)","Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and undergo blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.",[13,14,23,15,17,18],"Radiation: Hypofractionated Radiation Therapy",[25,39,48,58,71,79,84],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Antiandrogen Therapy","Receive ADT",[9,20],[31,32,33,34,35,36,37,38],"ADT","Androgen Deprivation Therapy","Androgen Deprivation Therapy (ADT)","Anti-androgen Therapy","Anti-androgen Treatment","Antiandrogen Treatment","Hormone Deprivation Therapy","Hormone-Deprivation Therapy",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,20],[45,46,47],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"RADIATION","Hypofractionated Radiation Therapy","Undergo hypofractionated radiation therapy",[20],[54,55,56,57],"Hypofractionated","Hypofractionated Radiotherapy","hypofractionation","Radiation, Hypofractionated",{"type":40,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Positron Emission Tomography","Undergo PET scan",[9,20],[63,64,65,66,67,68,69,70],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",{"type":49,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Stereotactic Body Radiation Therapy","Undergo SBRT",[9],[76,77,78],"SABR","SBRT","Stereotactic Ablative Body Radiation Therapy",{"type":6,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Survey Administration","Ancillary study",[9,20],null,{"type":40,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Magnetic Resonance Imaging","Undergo MRI",[9,20],[89,90,91,92,93,94,95,96,97,98,99,100],"Magnetic Resonance Imaging (MRI)","MRI","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","Structural MRI","sMRI","nuclear magnetic resonance imaging","NMRI","NMR Imaging","MRI Scan","MRIs",[102],{"name":103,"affiliation":5,"role":104},"Carlos E. Vargas, MD","PRINCIPAL_INVESTIGATOR",[106],{"name":107,"role":108,"phone":109,"phoneExt":83,"email":110},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[112,129,144,157,170,184],{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"Mayo Clinic in Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":121,"coordinates":122},"Point",[123,124],-111.89903,33.50921,{"lat":124,"lon":123},[127,128],{"name":107,"role":108,"phone":109,"phoneExt":83,"email":110},{"name":103,"role":104,"phone":83,"phoneExt":83,"email":83},{"facility":130,"status":131,"city":132,"state":133,"zip":134,"country":118,"countryCode":119,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Mayo Clinic Health System in Albert Lea","NOT_YET_RECRUITING","Albert Lea","Minnesota","56007",{"type":121,"coordinates":136},[137,138],-93.36827,43.64801,{"lat":138,"lon":137},[141,142],{"name":107,"role":108,"phone":109,"phoneExt":83,"email":110},{"name":143,"role":104,"phone":83,"phoneExt":83,"email":83},"John Yeakel, MD",{"facility":145,"status":131,"city":146,"state":133,"zip":147,"country":118,"countryCode":119,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Mayo Clinic Health System - Mankato","Mankato","56001",{"type":121,"coordinates":149},[150,151],-94.00915,44.15906,{"lat":151,"lon":150},[154,155],{"name":107,"role":108,"phone":109,"phoneExt":83,"email":110},{"name":156,"role":104,"phone":83,"phoneExt":83,"email":83},"Jason T. Hayes, MD",{"facility":158,"status":131,"city":159,"state":133,"zip":160,"country":118,"countryCode":119,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Mayo Clinic in Rochester","Rochester","55905",{"type":121,"coordinates":162},[163,164],-92.4699,44.02163,{"lat":164,"lon":163},[167,168],{"name":107,"role":108,"phone":109,"phoneExt":83,"email":110},{"name":169,"role":104,"phone":83,"phoneExt":83,"email":83},"Timothy D. Malouff, MD",{"facility":171,"status":131,"city":172,"state":173,"zip":174,"country":118,"countryCode":119,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Mayo Clinic Health System-Eau Claire Clinic","Eau Claire","Wisconsin","54701",{"type":121,"coordinates":176},[177,178],-91.49849,44.81135,{"lat":178,"lon":177},[181,182],{"name":107,"role":108,"phone":109,"phoneExt":83,"email":110},{"name":183,"role":104,"phone":83,"phoneExt":83,"email":83},"Now Bahar Alam, MD",{"facility":185,"status":131,"city":186,"state":173,"zip":187,"country":118,"countryCode":119,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Mayo Clinic Health System-Franciscan Healthcare","La Crosse","54601",{"type":121,"coordinates":189},[190,191],-91.23958,43.80136,{"lat":191,"lon":190},[194,195],{"name":107,"role":108,"phone":109,"phoneExt":83,"email":110},{"name":196,"role":104,"phone":83,"phoneExt":83,"email":83},"Abigail L. Stockham, MD",{"type":198,"investigatorFullName":83,"investigatorTitle":83,"investigatorAffiliation":83,"oldNameTitle":83,"oldOrganization":83},"SPONSOR","100531862","phase-3-sbrt-versus-hypofractionated-radiotherapy-for-biochemically-recurrent-or-oligometastatic-prostate-adenocarcinoma-100531862",false,"NCT06205316","SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma","Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma at the time of surgery\n* Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \\[AJCC\\] Criteria 8th edition \\[Ed.\\])\n* PSA post radical prostatectomy ≥ 0.1 and \\\u003C 2.0 ng\u002FmL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment\n* Patients must sign institutional review board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests within the specified time frames\n* Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration\n* Patients must be ≥ 18 years old\n* Prostate cancer up to oligometastatic disease, up to 5 sites\n\nExclusion Criteria:\n\n* Previous pelvic radiation\n* Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng\u002FmL\n* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)\n* Prior systemic chemotherapy for prostate cancer\n* History of proximal urethral stricture requiring dilatation\n* Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and\u002For interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)\n* History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months\n* On a transplant list\n* More than oligometastatic disease \\> 5 metastatic sites","MALE","18 Years",{"count":209,"type":210},118,"ESTIMATED","INTERVENTIONAL",[213],"PHASE3","This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.",[216,217,218,219,220,221,222],"Biochemically Recurrent Prostate Carcinoma","Oligometastatic Prostate Carcinoma","Recurrent Prostate Adenocarcinoma","Stage IIB Prostate Cancer AJCC v8","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","2026-01-16",{"date":225,"type":226},"2026-01-20","ACTUAL",{"date":228,"type":226},"2024-01-22",{"date":230,"type":210},"2030-01-22",{"name":5,"class":6},6]