[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531473":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":46,"responsibleParty":78,"collaborators":32,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":32,"eligibilityCriteria":85,"healthyVolunteers":82,"sex":86,"minAge":87,"maxAge":32,"enrollmentInfo":88,"targetDuration":32,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":32,"overallStatus":48,"whyStopped":32,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Covenant Health Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"\"Spot Delete\"","EXPERIMENTAL","A unique technique called \"Spot Delete\" will be utilized to control the placement of spots during treatment planning, to prohibit proton spots from being placed in the rectum, sigmoid, and small bowel. A specialized computer model will be used to study how the energy of the proton beam (linear energy transfer) is related to rectal and bladder side effects.",[13],"Radiation: Spot Delete planning for proton therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","ACTIVE_COMPARATOR","The proton spots that are placed by the treatment planning system are not modified",[19],"Radiation: Traditional proton treatment planning system",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Spot Delete planning for proton therapy","The method of adjusting the placement of proton spots or targets that are placed by the treatment planning system during pencil beam scanning for proton therapy",[9],[27],"Pencil beam scanning proton therapy",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Traditional proton treatment planning system","In the control arm, the proton spots placed by the treatment planning system are not modified.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Samantha Hedrick, PhD, DABR","Thompson Proton Center","PRINCIPAL_INVESTIGATOR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","865-862-1600","shedrick@covhlth.com",{"name":44,"role":40,"phone":41,"phoneExt":32,"email":45},"Catherine Duke-Taylor, BS","cduke@CovHlth.com",[47],{"facility":36,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Knoxville","Tennessee","37909","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-83.92074,35.96064,{"lat":58,"lon":57},[61,63,67,70,72,74,76],{"name":44,"role":40,"phone":62,"phoneExt":32,"email":45},"865-331-8216",{"name":64,"role":40,"phone":65,"phoneExt":32,"email":66},"Jessica M Severt, RN, BSN","865-331-4966","jsevert@covhlth.com",{"name":68,"role":69,"phone":32,"phoneExt":32,"email":32},"Ryan Grover, MD","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":32,"phoneExt":32,"email":32},"Brion Shin, MD",{"name":73,"role":69,"phone":32,"phoneExt":32,"email":32},"Allen Meek, MD",{"name":75,"role":69,"phone":32,"phoneExt":32,"email":32},"Chester Ramsey, PhD",{"name":77,"role":37,"phone":32,"phoneExt":32,"email":32},"Samantha Hedrick, PhD",{"type":79,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100531473","reduction-of-gastrointestinal-toxicity-in-prostate-cancer-by-proton-spot-placement-100531473",false,"NCT06200259","Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement","Inclusion Criteria:\n\n* Pathological proven diagnosis of prostatic adenocarcinoma\n* History and physical exam to establish clinical staging\n* Clinical stage T1-T2c (AJCC 7th edition)\n* Prostate specific antigen (PSA) \\\u003C 20 ng\u002FmL\n* Gleason Score ≤ 7\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1\n* Patients must be 18 years of age or older\n* Willingness and ability to complete the International Prostate Symptom Score (IPSS) survey and Expanded Prostate Cancer Index Composite (EPIC) questionnaire\n\nExclusion Criteria:\n\n* Prior radiotherapy to the pelvic area\n* Prior prostate cancer therapy: cryotherapy or hyperthermia\n* Prior systemic therapy (chemotherapy) for prostate cancer\n* Regional lymph nodes (common iliac, external iliac, internal iliac, presacral) are a target of treatment\n* Active diverticulitis, ulcerative colitis, or Crohn's disease","MALE","18 Years",{"count":89,"type":90},500,"ESTIMATED","INTERVENTIONAL",[93],"NA","This purpose of this study is to examine the placement of proton spots during pencil beam scanning proton therapy for low and intermediate risk prostate cancer. The researchers will test a unique technique called \"Spot Delete\" to control the placement of spots during treatment planning. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to rectal and bladder side effects. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The \"Spot Delete\" method prevents protons from stopping in the rectum, sigmoid, and small bowel, which is thought to be related to acute or late toxicities, such as tenesmus, diarrhea, fecal incontinence, proctitis, and rectal hemorrhage.",[96,97,98],"Prostate Cancer","Prostate Adenocarcinoma","Prostate Carcinoma","2025-12-16",{"date":101,"type":102},"2025-12-18","ACTUAL",{"date":104,"type":102},"2025-12-15",{"date":106,"type":90},"2040-01-02",{"name":5,"class":6},1]