[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501058":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":62,"studyPopulation":62,"armGroups":66,"interventions":73,"overallOfficials":79,"centralContacts":86,"locations":95,"responsibleParty":228,"collaborators":62,"id":230,"slug":231,"hasResults":232,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":232,"sex":238,"minAge":239,"maxAge":62,"enrollmentInfo":240,"targetDuration":62,"studyType":243,"phases":244,"briefSummary":245,"conditions":246,"keywords":62,"overallStatus":98,"whyStopped":62,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},{"fullName":5,"class":6},"Varian, a Siemens Healthineers Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Patient-reported acute urinary toxicity","Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.","90 days after end of SBRT",[14,18,22,25,28,31,35,38,40,42,44,48,51],{"measure":15,"description":16,"timeFrame":17},"Freedom from biochemical recurrence","Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng\u002Fml or more higher than the lowest post-SBRT value)","5 years after end of SBRT",{"measure":19,"description":20,"timeFrame":21},"Patient-reported quality of life issues related to prostate cancer.","Patient-reported quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.","Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT",{"measure":23,"description":24,"timeFrame":21},"Patient-reported erectile dysfunction symptoms","Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.",{"measure":26,"description":27,"timeFrame":21},"Patient-reported urinary symptoms","Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.",{"measure":29,"description":30,"timeFrame":21},"Patient-reported overall quality of life","Patient-reported overall quality of life before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire.",{"measure":32,"description":33,"timeFrame":34},"Physician-reported toxicities","Physician-reported CTCAE v 5.0 adverse events","During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT",{"measure":36,"description":37,"timeFrame":21},"Alpha-blocker medication use","Change in use of alpha-blocker medications for urinary symptoms",{"measure":39,"description":39,"timeFrame":17},"Metastasis-free survival",{"measure":41,"description":41,"timeFrame":17},"Prostate-cancer specific mortality",{"measure":43,"description":43,"timeFrame":17},"Overall survival",{"measure":45,"description":46,"timeFrame":47},"Workflow metrics of adaptive SBRT for prostate cancer","Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction.","2 weeks after start of SBRT",{"measure":49,"description":50,"timeFrame":47},"Target and OAR dosimetry","Improvement in target coverage and\u002For reduction in dose to critical organs at risk in the adapted plan compared to the non-adaptive planned dosimetry",{"measure":52,"description":53,"timeFrame":54},"Impact of rectal spacers","Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer","Enrollment through 5 year follow up",[56],{"measure":57,"description":58,"timeFrame":17},"Decipher prognostic ability","Correlation of the Decipher risk category (low\u002Fintermediate\u002Fhigh) with biochemical recurrence.",{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":62,"timePerspective":62,"maskingInfo":64},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":65,"maskingDescription":62,"whoMasked":62},"NONE",[67],{"label":68,"type":69,"description":70,"interventionNames":71},"Adaptive SBRT with Urethral Sparing","EXPERIMENTAL","Daily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra.",[72],"Device: Daily adaptive SBRT with urethral sparing",[74],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":62},"DEVICE","Daily adaptive SBRT with urethral sparing","The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.",[68],[80,84],{"name":81,"affiliation":82,"role":83},"Jonathan Leeman, MD","Brigham and Women's Hospital","PRINCIPAL_INVESTIGATOR",{"name":85,"affiliation":82,"role":83},"Jeremy Bredfeldt, PhD",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":62,"email":91},"Sean Davidson, MASc","CONTACT","1-437-991-8294","sean.davidson@siemens-healthineers.com",{"name":93,"role":89,"phone":62,"phoneExt":62,"email":94},"Claire McCann, PhD","claire.mccann@siemens-healthineers.com",[96,116,128,138,155,165,187,206],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Duarte Cancer Center","RECRUITING","Duarte","California","91010","United States","US",{"type":105,"coordinates":106},"Point",[107,108],-117.97729,34.13945,{"lat":108,"lon":107},[111,115],{"name":112,"role":89,"phone":113,"phoneExt":62,"email":114},"Percy Lee, MD","833-672-4068","percylee@coh.org",{"name":112,"role":83,"phone":62,"phoneExt":62,"email":62},{"facility":117,"status":98,"city":118,"state":100,"zip":119,"country":102,"countryCode":103,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"City of Hope Orange County Lennar Foundation Cancer Center","Irvine","92618",{"type":105,"coordinates":121},[122,123],-117.82311,33.66946,{"lat":123,"lon":122},[126,127],{"name":112,"role":89,"phone":113,"phoneExt":62,"email":114},{"name":112,"role":83,"phone":62,"phoneExt":62,"email":62},{"facility":82,"status":129,"city":130,"state":131,"zip":132,"country":102,"countryCode":103,"cosmosGeoPoint":133,"geoPoint":137,"contacts":62},"ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02115",{"type":105,"coordinates":134},[135,136],-71.05977,42.35843,{"lat":136,"lon":135},{"facility":139,"status":98,"city":140,"state":141,"zip":142,"country":102,"countryCode":103,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Washington University in St. Louis","St Louis","Missouri","63110",{"type":105,"coordinates":144},[145,146],-90.19789,38.62727,{"lat":146,"lon":145},[149,153],{"name":150,"role":89,"phone":151,"phoneExt":62,"email":152},"Lindsey Mayer, CCRP","314-482-9202","lindseymayer@wustl.edu",{"name":154,"role":83,"phone":62,"phoneExt":62,"email":62},"James Randall, MD",{"facility":156,"status":129,"city":157,"state":158,"zip":159,"country":102,"countryCode":103,"cosmosGeoPoint":160,"geoPoint":164,"contacts":62},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111",{"type":105,"coordinates":161},[162,163],-75.16362,39.95238,{"lat":163,"lon":162},{"facility":166,"status":98,"city":167,"state":168,"zip":169,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Klinikum der Landeshauptstadt Stuttgart gKAöR","Stuttgart","Baden-Wurttemberg","70174","Germany","DE",{"type":105,"coordinates":173},[174,175],9.17702,48.78232,{"lat":175,"lon":174},[178,182,186],{"name":179,"role":89,"phone":180,"phoneExt":62,"email":181},"Danilo Trijic, MD","04971127854668","D.Trijic@klinikum-stuttgart.de",{"name":183,"role":89,"phone":184,"phoneExt":62,"email":185},"Marc Münter, MD","04971127834201","M.Muenter@klinikum-stuttgart.de",{"name":183,"role":83,"phone":62,"phoneExt":62,"email":62},{"facility":188,"status":98,"city":189,"state":190,"zip":191,"country":170,"countryCode":171,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)","Homburg","Saarland","66421",{"type":105,"coordinates":193},[194,195],7.33867,49.32637,{"lat":195,"lon":194},[198,202,205],{"name":199,"role":89,"phone":200,"phoneExt":62,"email":201},"Markus Hecht, MD","0049 6841 16 24874","markus.hecht.clinicaltrials@uks.eu",{"name":203,"role":89,"phone":200,"phoneExt":62,"email":204},"Wiebke Pirschel, MSc","wiebke.pirschel@uks.eu",{"name":199,"role":83,"phone":62,"phoneExt":62,"email":62},{"facility":207,"status":98,"city":208,"state":209,"zip":210,"country":211,"countryCode":212,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Hospital Universitario de Navarra","Pamplona","Navarre","31008","Spain","ES",{"type":105,"coordinates":214},[215,216],-1.64323,42.81687,{"lat":216,"lon":215},[219,223,226],{"name":220,"role":89,"phone":221,"phoneExt":62,"email":222},"Marta Barrado Los Arcos, MD PhD","0034-848-488482","marta.barrado.losarcos@navarra.es",{"name":224,"role":89,"phone":221,"phoneExt":62,"email":225},"Elena Villafranca Iturre, MD","elena.villafranca.iturre@navarra.es",{"name":227,"role":83,"phone":62,"phoneExt":62,"email":62},"Marta Barrado Los Arcos, MD",{"type":229,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100501058","daily-adaptive-radiation-therapy-using-an-individualized-approach-for-prostate-cancer-100501058",false,"NCT05804318","Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer","Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity","ARTIA-Prostate","Inclusion Criteria:\n\n1. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.\n2. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.\n3. AUA\u002FIPSS score is ≤ 15.\n4. ECOG performance status is ≤2 (or Karnofsky score is ≥60%).\n5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).\n6. Patient has the ability to complete required patient questionnaires.\n7. Patient age ≥ 18 years (or greater than the local age of majority).\n8. Patient has the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has baseline grade ≥3 GI or GU toxicity\n2. Patient has had prior overlapping pelvic radiotherapy.\n3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.\n4. Patient has node positive prostate cancer.\n5. Patient has extracapsular extension (capsular abutment is permitted).\n6. Patient has active inflammatory bowel disease or active collagen vascular disease.\n7. Patient cannot undergo prostate MRI.\n8. Patient cannot undergo prostate fiducial marker placement.\n9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).","MALE","18 Years",{"count":241,"type":242},132,"ESTIMATED","INTERVENTIONAL",[60],"This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.",[247],"Prostate Cancer","2026-09-08",{"date":250,"type":251},"2026-09-09","ACTUAL",{"date":253,"type":251},"2023-04-13",{"date":255,"type":242},"2031-10",{"name":5,"class":6},8]