[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566084":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":149,"centralContacts":154,"locations":161,"responsibleParty":206,"collaborators":209,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":159,"eligibilityCriteria":227,"healthyVolunteers":223,"sex":228,"minAge":229,"maxAge":159,"enrollmentInfo":230,"targetDuration":159,"studyType":233,"phases":234,"briefSummary":236,"conditions":237,"keywords":241,"overallStatus":164,"whyStopped":159,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Emory University","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (leuprolide plus abiraterone acetate\u002Fprednisone)","EXPERIMENTAL","Patients receive leuprolide IM or SC injections every 3 to 6 months plus oral abiraterone acetate (AA) with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy.",[13,14,15,16,17,18,19],"Drug: Abiraterone Acetate","Drug: Bicalutamide","Procedure: Biospecimen Collection","Procedure: Computed Tomography Angiography","Drug: Leuprolide","Drug: Prednisone","Radiation: Radiation Therapy",{"label":21,"type":10,"description":22,"interventionNames":23},"Arm II (relugolix + abiraterone acetate\u002Fprednisone)","Patients receive oral relugolix daily plus oral abiraterone acetate (AA) with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy.",[13,15,16,18,19,24],"Drug: Relugolix",[26,40,51,60,68,74,121,139],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Abiraterone Acetate","Given abiraterone acetate",[9,21],[32,33,34,35,36,37,38,39],"BR9004","BR9004-1","CB 7630","CB-7630","CB7630","JNJ-212082","Yonsa","Zytiga",{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Bicalutamide","Given PO",[9],[45,46,47,48,49,50],"Casodex","Cassotide","Cosudex","ICI 176,334","ICI 176334","Utamide",{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,21],[57,58,59],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Computed Tomography Angiography","Undergo CCTA",[9,21],[65,66,67],"CT ANGIOGRAPHY","CT Scan Angiography","CTA",{"type":27,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Leuprolide","Given IM or SC",[9],[73],"Leuprorelin",{"type":27,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"Prednisone","Given prednisone",[9,21],[79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],".delta.1-Cortisone","1, 2-Dehydrocortisone","Adasone","Cortancyl","Dacortin","DeCortin","Decortisyl","Decorton","Delta 1-Cortisone","Delta-Dome","Deltacortene","Deltacortisone","Deltadehydrocortisone","Deltasone","Deltison","Deltra","Econosone","Lisacort","Meprosona-F","Metacortandracin","Meticorten","Ofisolona","Orasone","Panafcort","Panasol-S","Paracort","Perrigo Prednisone","PRED","Predicor","Predicorten","Prednicen-M","Prednicort","Prednidib","Prednilonga","Predniment","Prednisone Intensol","Prednisonum","Prednitone","Promifen","Rayos","Servisone","SK-Prednisone",{"type":122,"name":123,"description":124,"armGroupLabels":125,"otherNames":126},"RADIATION","Radiation Therapy","Undergo standard of care radiation therapy",[9,21],[127,128,129,130,131,132,133,134,135,136,137,138],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":27,"name":140,"description":42,"armGroupLabels":141,"otherNames":142},"Relugolix",[21],[143,144,145,146,147,148],"N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea","Orgovyx","Relumina","TAK 385","TAK-385","TAK385",[150],{"name":151,"affiliation":152,"role":153},"Sagar A Patel, MD","Emory University Hospital\u002FWinship Cancer Institute","PRINCIPAL_INVESTIGATOR",[155],{"name":156,"role":157,"phone":158,"phoneExt":159,"email":160},"Bill Zheng, BS","CONTACT","404-686-6856",null,"bill.zheng@emory.edu",[162,179,186,198],{"facility":163,"status":164,"city":165,"state":166,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":175,"contacts":176},"Emory Proton Therapy Center","RECRUITING","Atlanta","Georgia","30308","United States","US",{"type":171,"coordinates":172},"Point",[173,174],-84.38798,33.749,{"lat":174,"lon":173},[177],{"name":178,"role":157,"phone":158,"phoneExt":159,"email":160},"Bill Zheng",{"facility":180,"status":164,"city":165,"state":166,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":181,"geoPoint":183,"contacts":184},"Winship at Emory Midtown",{"type":171,"coordinates":182},[173,174],{"lat":174,"lon":173},[185],{"name":178,"role":157,"phone":158,"phoneExt":159,"email":160},{"facility":152,"status":164,"city":165,"state":166,"zip":187,"country":168,"countryCode":169,"cosmosGeoPoint":188,"geoPoint":190,"contacts":191},"30322",{"type":171,"coordinates":189},[173,174],{"lat":174,"lon":173},[192,196],{"name":193,"role":157,"phone":194,"phoneExt":159,"email":195},"Sagar A. Patel, MD","404-686-4835","Sagar.patel@emory.edu",{"name":197,"role":153,"phone":159,"phoneExt":159,"email":159},"Sagar A. Patel",{"facility":199,"status":164,"city":165,"state":166,"zip":200,"country":168,"countryCode":169,"cosmosGeoPoint":201,"geoPoint":203,"contacts":204},"Emory Saint Joseph's Hospital","30342",{"type":171,"coordinates":202},[173,174],{"lat":174,"lon":173},[205],{"name":178,"role":157,"phone":158,"phoneExt":159,"email":160},{"type":153,"investigatorFullName":207,"investigatorTitle":208,"investigatorAffiliation":5,"oldNameTitle":159,"oldOrganization":159},"Sagar Patel","Principal Investigator",[210,213,215,218],{"name":211,"class":212},"Pfizer","INDUSTRY",{"name":214,"class":212},"Sumitomo Pharma America, Inc.",{"name":216,"class":217},"National Comprehensive Cancer Network","NETWORK",{"name":219,"class":220},"National Cancer Institute (NCI)","NIH","100566084","phase-3-revelution-2-relugolixabiraterone-acetate-aa-versus-leuprolideaa-cardiac-trial-100566084",false,"NCT06650579","REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial","Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial","Inclusion Criteria:\n\n* Men ≥ 18 years old\n* Non-metastatic prostate cancer\n* Non-metastatic, biochemically recurrent prostate cancer\n* Plan to undergo curative-intent pelvic radiation therapy (photons or protons) with or without brachytherapy\n* Plan to undergo up to 24 months of combination androgen deprivation therapy (ADT) plus AA and prednisone\n\nExclusion Criteria:\n\n* Metastatic prostate cancer requiring indefinitive ADT or chemotherapy\n* Prior exposure to androgen deprivation therapy\n* Prior exposure to chemotherapy, immunotherapy, or radiation therapy\n* History of cardiac bypass surgery or percutaneous coronary intervention\n* History of cardiac pacemaker or defibrillator","MALE","18 Years",{"count":231,"type":232},72,"ESTIMATED","INTERVENTIONAL",[235],"PHASE3","This phase III\u002FIV trial compares the impact of leuprolide and abiraterone acetate (AA) versus relugolix and AA on the heart in hormone-naive patients with advanced prostate cancer receiving pelvic radiation therapy. Leuprolide is in a class of medications called gonadotropin-releasing hormone agonists (GNRHa). It prevents the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate tumor cells that need testosterone to grow. Abiraterone acetate, an androgen biosynthesis inhibitor, works by decreasing the amount of certain hormones in the body. Relugolix, a GNRH antagonist, works by decreasing the amount of testosterone produced by the body. This may slow or stop the spread of prostate tumor cells that need testosterone to grow. The use of hormone therapy with radiation therapy has been shown to improve survival, however, studies have suggested that the addition of hormone therapy may worsen heart (cardiac) disease and high blood pressure. In fact, studies have shown that the most common cause of death in prostate cancer patients is due to heart disease or heart attacks. Computed tomography (CT) scans create a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. In this study, sophisticated cardiac CT images are used to take pictures of patients' heart and coronary arteries to help assess damage to the heart. Using cardiac CT and blood tests, this trial may help doctors determine which patients are at risk of cardiac disease when treated with combination hormone therapy, as well as the differential risk of leuprolide versus relugolix in combination with abiraterone acetate.",[238,239,240],"Recurrent Prostate Carcinoma","Stage III Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8",[242,243,244],"node-positive prostate cancer","advanced prostate cancer","very-high-risk prostate cancer","2026-02-22",{"date":247,"type":248},"2026-02-24","ACTUAL",{"date":250,"type":248},"2025-01-31",{"date":252,"type":232},"2029-07-01",{"name":5,"class":6},4]