[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100318369":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":64,"collaborators":28,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":28,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":28,"enrollmentInfo":75,"targetDuration":28,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":28,"overallStatus":40,"whyStopped":28,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"HDR brachytherapy - 21 Gy","EXPERIMENTAL","-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy.",[13],"Radiation: HDR brachytherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"HDR brachytherapy - 23 Gy","-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"HDR brachytherapy - 25 Gy","-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","HDR brachytherapy","* Dose constraints for 21 Gy:\n\n  * Bladder and rectum: V70 \\\u003C 1 cc\n  * Urethra: V115 \\\u003C 1 cc\n  * V135: 0%\n* Dose constraints for 23 Gy:\n\n  * Bladder and rectum: V65 \\\u003C 1 cc\n  * Urethra: V105 \\\u003C 1 cc\n  * V125: 0%\n* Dose constraints for 25 Gy:\n\n  * Prostate V100 \\>90% (\\>95% preferred)\n  * Bladder and rectum: V70 \\\u003C 1 cc, Dmax \\\u003C115%\n  * Urethra: V110 \\\u003C 1 cc, Dmax \\\u003C120%",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Hiram A Gay, M.D.","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},"CONTACT","314-362-8516","hiramgay@wustl.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-90.19789,38.62727,{"lat":50,"lon":49},[53,54,55,58,60,62],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},{"name":31,"role":32,"phone":28,"phoneExt":28,"email":28},{"name":56,"role":57,"phone":28,"phoneExt":28,"email":28},"Jeff M Michalski, M.D.","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":28,"phoneExt":28,"email":28},"Joshua Schiff, M.D.",{"name":61,"role":57,"phone":28,"phoneExt":28,"email":28},"Trevor Zimmerman",{"name":63,"role":57,"phone":28,"phoneExt":28,"email":28},"Michael Altman, Ph.D.",{"type":65,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100318369","phase-1-safety-and-efficacy-of-21-gy-23-gy-and-25-gy-for-high-dose-rate-hdr-prostate-brachytherapy-100318369",false,"NCT03424850","Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy","A Phase I\u002FII Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of early stage prostate cancer.\n* Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA \\\u003C 10 ng\u002FmL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores \\\u003C 50%, no more than one NCCN intermediate risk factor).\n* Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.\n* A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.\n* Currently receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Unable to undergo general, spinal or local anesthesia.\n* Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.","MALE","18 Years",{"count":76,"type":77},36,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.",[84,85],"Prostate Cancer","Prostate Neoplasm","2026-03-10",{"date":88,"type":89},"2026-03-11","ACTUAL",{"date":91,"type":89},"2018-02-27",{"date":93,"type":77},"2030-02-28",{"name":5,"class":6},1]