[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526062":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":142,"centralContacts":130,"locations":147,"responsibleParty":167,"collaborators":169,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":130,"eligibilityCriteria":179,"healthyVolunteers":175,"sex":180,"minAge":181,"maxAge":130,"enrollmentInfo":182,"targetDuration":130,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":130,"overallStatus":193,"whyStopped":130,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"University of Kansas Medical Center","OTHER",[8,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (relugolix, brachytherapy, external beam radiation)","EXPERIMENTAL","Patients receive relugolix PO QD. Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.",[13,14,15,16,17,18,19,20,21,22],"Procedure: Biospecimen Collection","Procedure: Bone Scan","Radiation: Brachytherapy","Procedure: Computed Tomography","Procedure: Dual X-ray Absorptiometry","Radiation: External Beam Radiation Therapy","Procedure: Magnetic Resonance Imaging","Procedure: PSMA PET Scan","Other: Questionnaire Administration","Drug: Relugolix",{"label":24,"type":10,"description":25,"interventionNames":26},"Arm B (relugolix, brachytherapy, external beam radiation)","Patients receive relugolix PO QD. Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.",[13,14,15,16,17,18,19,20,21,22],[28,37,43,55,69,84,102,118,126,131],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,24],[34,35,36],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Bone Scan","Undergo bone scan",[9,24],[42],"Bone Scintigraphy",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"RADIATION","Brachytherapy","Undergo brachytherapy",[9,24],[49,50,51,52,53,54],"Brachytherapy, NOS","Internal Radiation","Internal Radiation Brachytherapy","Internal Radiation Therapy","Radiation Brachytherapy","Radiation, Internal",{"type":29,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Computed Tomography","Undergo CT",[9,24],[60,61,62,63,64,65,66,67,68],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography",{"type":29,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Dual X-ray Absorptiometry","Undergo DEXA scan",[9,24],[74,75,76,77,78,79,80,81,82,83],"BMD scan","bone mineral density scan","DEXA","DEXA (Bone Density)","DEXA Scan","dual energy x-ray absorptiometric scan","Dual Energy X-ray Absorptiometry","Dual X-Ray Absorptometry","DXA","DXA SCAN",{"type":44,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"External Beam Radiation Therapy","Undergo external beam radiation therapy",[9,24],[89,90,91,92,93,94,95,96,97,98,99,100,101],"Definitive Radiation Therapy","EBRT","External Beam Radiation","External Beam Radiotherapy","External Beam Radiotherapy (conventional)","External Beam RT","external radiation","External Radiation Therapy","external-beam radiation","Radiation, External Beam","Teleradiotherapy","Teletherapy","Teletherapy Radiation",{"type":29,"name":103,"description":104,"armGroupLabels":105,"otherNames":106},"Magnetic Resonance Imaging","Undergo MRI",[9,24],[107,108,109,110,111,112,113,114,115,116,117],"Magnetic Resonance","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging",{"type":29,"name":119,"description":120,"armGroupLabels":121,"otherNames":122},"PSMA PET Scan","Undergo PSMA PET",[9,24],[123,124,125],"Prostate-specific Membrane Antigen PET","PSMA PET","PSMA-Positron emission tomography",{"type":6,"name":127,"description":128,"armGroupLabels":129,"otherNames":130},"Questionnaire Administration","Ancillary studies",[9,24],null,{"type":132,"name":133,"description":134,"armGroupLabels":135,"otherNames":136},"DRUG","Relugolix","Given PO",[9,24],[137,138,139,140,141],"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",[143],{"name":144,"affiliation":145,"role":146},"Xinglei Shen","University of Kansas","PRINCIPAL_INVESTIGATOR",[148],{"facility":149,"status":130,"city":150,"state":151,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":160,"contacts":161},"University of Kansas Cancer Center","Kansas City","Kansas","66160","United States","US",{"type":156,"coordinates":157},"Point",[158,159],-94.62746,39.11417,{"lat":159,"lon":158},[162,166],{"name":144,"role":163,"phone":164,"phoneExt":130,"email":165},"CONTACT","913-588-3600","xshen@kumc.edu",{"name":144,"role":146,"phone":130,"phoneExt":130,"email":130},{"type":146,"investigatorFullName":144,"investigatorTitle":168,"investigatorAffiliation":145,"oldNameTitle":130,"oldOrganization":130},"Principal Investigator",[170],{"name":171,"class":172},"National Cancer Institute (NCI)","NIH","100526062","phase-2-relugolix-in-combination-with-radiation-therapy-for-treating-patients-with-high-risk-prostate-cancer-100526062",false,"NCT06129851","Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer","Quantifying Optimal Relugolix Duration With Radiation in High Risk Prostate Cancer (QURE-PC)","Inclusion Criteria:\n\n* Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1\n* Life expectancy \\> 5 years\n* Patient diagnosed with National Comprehensive Cancer Network (NCCN) high risk and very high risk prostate cancer.\n\n  * High risk is defined as:\n\n    * T3a or\n    * Grade group 4 or 5 or\n    * Prostate-specific antigen (PSA) \\> 20 ng\u002FmL\n  * Very high risk is defined as:\n\n    * T3b to T4 or\n    * Primary Gleason pattern 5 or\n    * Two or three high-risk features or\n    * \\> 4 cores with grade group 4 or 5\n* Eligible for treatment with combination brachytherapy, external beam radiation, and ADT\n* Leukocytes \\>= 1.0 K\u002FUL\n* Platelets \\>= 100 K\u002FUL\n* Hemoglobin ≥ 9 g\u002FdL\n* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN)\n* Men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed for the duration of study participation and for 2 weeks following completion of relugolix therapy\n\nExclusion Criteria:\n\n* Simultaneously enrolled in any therapeutic clinical trial\n* Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study\n* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n* Has a known allergic reaction to any excipient or component contained in the study drug formulation\n* Active grade 3 (per the National Cancer Institute \\[NCI\\] CTCAE, version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment\n* Current androgen deprivation therapy (unless testosterone \\> 50 ng\u002FdL). Please note prior or concurrent bicalutamide at 50 mg\u002Fdaily or less is allowed. Prior androgen deprivation therapy is allowed if testosterone has recovered to \\> 50 ng\u002FdL\n* Prolonged echocardiogram corrected QT (QTc) interval \\> 440 ns\n* Prior pelvic therapy that would significantly overlap with radiation treatment fields\n* Prior prostatectomy","MALE","18 Years",{"count":183,"type":184},90,"ESTIMATED","INTERVENTIONAL",[187],"PHASE2","This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). ADT is used to lower the amount of testosterone in the body, because testosterone appears to help prostate cancer grow. Relugolix works to reduce testosterone levels, which may inhibit proliferation of prostate cancer cells. It is approved by the Food and Drug Administration to treat prostate cancer. Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy, but the optimal duration of relugolix in combination with radiation is not known.",[190,191,192],"Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","NOT_YET_RECRUITING","2023-11-03",{"date":196,"type":197},"2023-11-13","ACTUAL",{"date":199,"type":184},"2023-11-20",{"date":201,"type":184},"2026-10-23",{"name":5,"class":6},1]