[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544494":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":136,"centralContacts":140,"locations":146,"responsibleParty":164,"collaborators":117,"id":166,"slug":167,"hasResults":168,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":117,"eligibilityCriteria":172,"healthyVolunteers":168,"sex":173,"minAge":174,"maxAge":117,"enrollmentInfo":175,"targetDuration":117,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":117,"overallStatus":149,"whyStopped":117,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Group I (radiation therapy)","EXPERIMENTAL","Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.",[13,14,15,16,17,18],"Procedure: Biospecimen Collection","Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging","Procedure: Positron Emission Tomography","Other: Questionnaire Administration","Radiation: Radiation Therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Group II (ADT, radiation therapy)","Patients receive ADT SC or IM for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.",[13,14,23,15,16,17,18],"Biological: Gonadotropin-releasing Hormone Analog",{"label":25,"type":10,"description":26,"interventionNames":27},"Group III (ADT, radiation therapy, abiraterone acetate)","Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.",[28,13,14,23,15,16,17,18],"Drug: Abiraterone Acetate",[30,42,51,66,81,101,113,118],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Abiraterone Acetate","Given abiraterone acetate",[25],[36,37,38,39,40,41],"BR9004","BR9004-1","CB7630","JNJ-212082","Yonsa","Zytiga",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,20,25],[48,49,50],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":43,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Computed Tomography","Undergo CT",[9,20,25],[56,57,58,59,60,61,62,63,64,65],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"BIOLOGICAL","Gonadotropin-releasing Hormone Analog","Given SC or IM",[20,25],[72,73,74,75,76,77,78,79,80],"GnRH Agonist","GnRH Analog","Gonadotropin-Releasing Hormone Agonist","Gonadotropin-Releasing Hormone Analogue","LH-RH agonist","LH-RH Analogs","LHRH Agonist","luteinizing hormone-releasing hormone agonist","Luteinizing Hormone-Releasing Hormone Analog",{"type":43,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"Magnetic Resonance Imaging","Undergo MRI",[9,20,25],[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":43,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"Positron Emission Tomography","Undergo PET",[9,20,25],[106,107,108,109,110,111,112],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":6,"name":114,"description":115,"armGroupLabels":116,"otherNames":117},"Questionnaire Administration","Ancillary studies",[9,20,25],null,{"type":119,"name":120,"description":121,"armGroupLabels":122,"otherNames":123},"RADIATION","Radiation Therapy","Undergo radiation therapy",[9,20,25],[124,125,126,127,128,129,130,131,132,133,134,135],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",[137],{"name":138,"affiliation":5,"role":139},"Carlos E. Vargas, M.D.","PRINCIPAL_INVESTIGATOR",[141],{"name":142,"role":143,"phone":144,"phoneExt":117,"email":145},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[147],{"facility":148,"status":149,"city":150,"state":151,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":160,"contacts":161},"Mayo Clinic in Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":156,"coordinates":157},"Point",[158,159],-111.89903,33.50921,{"lat":159,"lon":158},[162,163],{"name":142,"role":143,"phone":144,"phoneExt":117,"email":145},{"name":138,"role":139,"phone":117,"phoneExt":117,"email":117},{"type":165,"investigatorFullName":117,"investigatorTitle":117,"investigatorAffiliation":117,"oldNameTitle":117,"oldOrganization":117},"SPONSOR","100544494","phase-2-risk-stratified-de-escalated-hormone-therapy-with-radiation-therapy-for-the-treatment-of-prostate-cancer-100544494",false,"NCT06369610","Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer","Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging","Inclusion Criteria:\n\n* Histologically confirmed high risk prostate adenocarcinoma\n* Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition \\[Ed\\].)\n* One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must sign institutional review board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests\n* Patients must be at least 18 years old\n* Oligometastatic prostate cancer defined as disease in up to 5 distant or regional areas (group 3 only)\n\nExclusion Criteria:\n\n* Previous pelvic radiation\n* Prior androgen suppression therapy for prostate cancer for more than 6 months\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* Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low-molecular weight heparin, clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)\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* Evidence of any other cancer within the past 5 years and \\\u003C 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)\n* History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months","ALL","18 Years",{"count":176,"type":177},110,"ESTIMATED","INTERVENTIONAL",[180],"PHASE2","This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.",[183,184],"Oligometastatic Prostate Carcinoma","Prostate Adenocarcinoma","2025-11-12",{"date":187,"type":188},"2025-11-14","ACTUAL",{"date":190,"type":188},"2024-04-22",{"date":192,"type":177},"2027-04-22",{"name":5,"class":6},1]