[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03424850":3,"trial-entities:NCT03424850":109,"trial-summary:NCT03424850":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":52,"minimum_age":53,"maximum_age":17,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":71,"locations":74,"central_contacts":100,"overall_officials":102,"references":104,"see_also_links":105},"NCT03424850","201801118","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","RECRUITING","2030-02-28","2026-03","2026-03-11","2018-02-27","Washington University School of Medicine","OTHER",true,"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.",null,[19,20],"Prostate Cancer","Prostate Neoplasm",[],"INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},36,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"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%",[36,37,38],"HDR brachytherapy - 21 Gy","HDR brachytherapy - 23 Gy","HDR brachytherapy - 25 Gy",[40],{"measure":41,"description":42,"timeFrame":43},"Biochemical control experienced by patients with prostate cancer treated with an HDR implant","-Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng\u002FmL or more above the PSA nadir","Through 3 years after implant",[45,49],{"measure":46,"description":47,"timeFrame":48},"Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant","-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.","From start of treatment through 90 days",{"measure":50,"description":47,"timeFrame":51},"Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant","From day 91 through 3 years after implant","MALE","18 Years",false,{"inclusion":56,"exclusion":63,"raw_text":70},[57,58,59,60,61,62],"Histologically or cytologically confirmed diagnosis of early stage prostate cancer.","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).","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.","At least 18 years of age.","ECOG performance status ≤ 2","Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).",[64,65,66,67,68,69],"Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.","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.","Currently receiving any other investigational agents.","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.","Unable to undergo general, spinal or local anesthesia.","Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.","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.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":97},"St Louis","Missouri","63110","United States",[81,86,88,91,93,95],{"name":82,"role":83,"phone":84,"email":85},"Hiram A Gay, M.D.","CONTACT","314-362-8516","hiramgay@wustl.edu",{"name":82,"role":87},"PRINCIPAL_INVESTIGATOR",{"name":89,"role":90},"Jeff M Michalski, M.D.","SUB_INVESTIGATOR",{"name":92,"role":90},"Joshua Schiff, M.D.",{"name":94,"role":90},"Trevor Zimmerman",{"name":96,"role":90},"Michael Altman, Ph.D.",{"lat":98,"lon":99},38.62727,-90.19789,[101],{"name":82,"role":83,"phone":84,"email":85},[103],{"name":82,"affiliation":13,"role":87},[],[106],{"label":107,"url":108},"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","http:\u002F\u002Fwww.siteman.wustl.edu",{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Prostate Carcinoma",[113],"KLK3 Gene",{"nct_id":4,"found":15,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study with a planned enrollment of 36 participants, exploring different doses of HDR brachytherapy.","completed","HDR Brachytherapy for Early Stage Prostate Cancer","This study is looking at different doses of high dose rate (HDR) brachytherapy to treat early stage prostate cancer. HDR brachytherapy is a type of radiation therapy where a radioactive source is temporarily placed inside the prostate. Researchers want to understand the results and side effects of using 21 Gy, 23 Gy, or 25 Gy doses of this treatment. You might be able to join if you are a man aged 18 or older with early stage prostate cancer that is considered low-risk or favorable intermediate-risk. The main goal is to see how well the treatment controls the cancer, specifically by measuring \"biochemical control\" (how well the treatment reduces certain markers in your blood) for up to three years after the treatment.","The study will follow participants to measure biochemical control for up to three years after the HDR implant.",122,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]