[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654679":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":48,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":86,"collaborators":33,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":33,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":33,"enrollmentInfo":97,"targetDuration":33,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":75,"whyStopped":33,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"NYU Langone Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"5-Year Cumulative Incidence of Distant Metastases","Incidence of distant metastases (DM). DM is defined as the first occurrence of radiographic or biopsy-confirmed distant metastatic disease.","Up to Year 5",[14,17,20,23,27,30],{"measure":15,"description":16,"timeFrame":12},"Distant Metastasis-Free Survival (DMFS)","Defined as the time from study enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.",{"measure":18,"description":19,"timeFrame":12},"Time to Biochemical Failure","Time to biochemical failure will be measured from study enrollment to the date when the Phoenix criterion (PSA nadir + 2 ng\u002FmL) is first met.",{"measure":21,"description":22,"timeFrame":12},"Overall Survival (OS)","Defined as the time from study enrollment to death from any cause.",{"measure":24,"description":25,"timeFrame":26},"Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score","26-item survey assessing prostate cancer-related symptom domains. Each item is rated on a Likert score. The raw score is the sum of responses and is converted to a standard score from 0-100, where higher scores indicate greater quality of life.","Baseline, Year 2",{"measure":28,"description":29,"timeFrame":26},"Change in International Prostate Symptom Score (IPSS) Score","7-item assessment of the severity of lower urinary tract symptoms linked to benign prostatic hyperplasia (BPH). Each item is rated on a Likert scale. The total score is the sum of responses and ranges from 0-35; lower scores indicate milder symptoms.",{"measure":31,"description":32,"timeFrame":26},"Change in Short-Form-12 (SF-12) Score","12-item assessment of health and quality of life. Each item is rated on a Likert scale. The raw score is the sum of responses and is converted to a standard score between 0-100; higher scores indicate better quality of life.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores","EXPERIMENTAL","Patients will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes.",[46,47],"Drug: Androgen Deprivation Therapy (ADT)","Radiation: Radiotherapy",[49,58],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Androgen Deprivation Therapy (ADT)","ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.",[42],[55,56,57],"Degarelix","Leuprolide","Relugolix",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":33},"RADIATION","Radiotherapy","Dose-escalated radiotherapy.",[42],[64],{"name":65,"affiliation":5,"role":66},"Michael Zelefsky, MD","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":33,"email":72},"Nina Yang, RN","CONTACT","646-830-4743","Nina.Yang@nyulangone.org",[74],{"facility":5,"status":75,"city":76,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":33},"RECRUITING","New York","10016","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-74.00597,40.71427,{"lat":84,"lon":83},{"type":87,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100654679","phase-2-short-course-adt-for-high-risk-lowintermediate-risk-artera-prostate-cancer-100654679",false,"NCT07801664","Short Course ADT for High Risk Low\u002FIntermediate Risk ARTERA Prostate Cancer","A Phase II Prospective Trial Utilizing Short Course Androgen Deprivation Therapy In Conjunction With Ultra-Hypofractionated SBRT For High Risk Nccn Prostate Cancer With Lower Risk Artera Scores","Inclusion Criteria:\n\n* Ability to understand and willingness to sign a written informed consent document\n* 18 years of age or older male participants\n* Biopsy proven prostate cancer meeting at least one of the following high-risk criteria: Gleason score 8-10 OR; Baseline PSA \\>20 up to and including 40 ng\u002Fml OR; Patients with Gleason score 6-7 remain eligible if the PSA criterion (\\>20 ng\u002FmL) is met OR; MRI Radiographic stage T1-T3 disease without evidence of nodal involvement\n* No imaging evidence of nodal metastases on baseline MRI\u002F CT of the pelvis and PET-PSMA scans\n* Low risk or intermediate risk ARTERA AI scores\n* Serum testosterone ≥ 120 ng\u002FdL determined prior to ADT start\n* At least 4 weeks must have elapsed from major surgery\n* Karnofsky Performance Status (KPS) \\> 80\n* Prostate size \\\u003C 90 cc\n* MRI findings: Lesion may have extracapsular extension (ECE)\n* International Prostate Symptom Score (IPSS) \\\u003C 22\n* Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form\n\nExclusion Criteria:\n\n* Gleason score 6 or 7 in the absence of PSA \\>20 ng\u002FmL\n* PSA \\>40 ng\u002FmL\n* Prior or concurrent androgen deprivation therapy for prostate cancer of \\>3 months duration\n* High Risk ARTERA scores\n* MRI findings: suspicious nodal metastases\n* Evidence of regional lymphadenopathy or metastatic disease on MRI\u002FCT or PSMA PET scan\n* Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI\n* Contra-indications to receiving gadolinium contrast\n* KPS \\\u003C 80\n* Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T4, or N1 disease or bone disease\n* Prior treatment for prostate cancer, including history of chemotherapy or surgery for prostate cancer (except for prior \\[transurethral resection of prostate\\] TURP or greenlight \\[photo selective vaporization of prostate\\] PVP which would be allowed)\n* History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years. Patients with Crohn's disease or ulcerative colitis\n* IPSS \\> 22\n* Currently on any ARPis (including but not limited to: enzalutamide, apalutamide, darolutamide, or abiraterone)\n* Prior pharmacologic androgen deprivation therapy (ADT) for prostate cancer is permitted under the following (2) conditions: 1) Participants meeting this criterion will be assigned to a separate stratum within each primary treatment cohort. 2) Patients remain eligible for enrollment provided they have received no more than 3 months of ADT in total, regardless of whether ADT was initiated before screening or registration.","MALE","18 Years",{"count":98,"type":99},90,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","For this study, high risk prostate cancer patients with lower risk ARTERA scores will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. Specifically, patients enrolled in this study will undergo one of several dose-escalated forms of radiotherapy which would include SBRT with or without a brachytherapy boost.",[105],"Prostate Cancer",[107],"high-risk prostate cancer","2026-08-31",{"date":110,"type":111},"2026-09-03","ACTUAL",{"date":113,"type":111},"2026-08-06",{"date":115,"type":99},"2029-08-01",{"name":5,"class":6},1]