[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07574489":3,"trial-entities:NCT07574489":122,"trial-summary:NCT07574489":126},{"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":33,"primary_purpose":34,"phases":35,"enrollment_info":38,"interventions":41,"primary_outcomes":53,"secondary_outcomes":61,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":83,"eligibility_criteria":84,"std_ages":88,"locations":91,"central_contacts":107,"overall_officials":116,"references":120,"see_also_links":121},"NCT07574489","Gland Boost","Whole Versus Partial Gland Boost During Prostate SBRT","Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)","NOT_YET_RECRUITING","2035-08-25","2026-04","2026-06-29","2026-07-25","University of Nebraska","OTHER",true,"This phase 2\u002F3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.","This is a phase 2\u002F3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.\n\nIn both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI).\n\nThe primary objective is to evaluate chronic genitourinary (GU) and gastrointestinal (GI) toxicities grade 2 or higher from 6 months to 2 years post-treatment using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary objectives include evaluation of acute and chronic GU and GI toxicities using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains, as well as biochemical progression-free survival at 5 years.\n\nParticipants will be followed for up to 5 years after completion of treatment.",[19,20],"Prostate Cancer","Prostate Adenocarcinoma",[22,23,24,25,26,27,28,29,30,31,32],"Prostate SBRT","Stereotactic Body Radiotherapy","Dose Escalation","Dominant Intraprostatic Lesion","DIL","Radiation Therapy","Genitourinary Toxicity","Gastrointestinal Toxicity","CTCAE","RTOG","EPIC","INTERVENTIONAL","TREATMENT",[36,37],"PHASE2","PHASE3",{"count":39,"type":40},186,"ESTIMATED",[42,48],{"type":43,"name":44,"description":45,"armGroupLabels":46},"RADIATION","Prostate stereotactic body radiotherapy with whole gland boost","External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost",[47],"Arm A: boost to prostate alone",{"type":43,"name":49,"description":50,"armGroupLabels":51},"Prostate stereotactic body radiotherapy with DIL boost","External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.",[52],"Arm B: boost to dominant intra-prostatic lesion (DIL)",[54,58],{"measure":55,"description":56,"timeFrame":57},"Grade 2 or Higher Chronic Genitourinary Toxicity","Cumulative incidence of grade 2 or higher chronic genitourinary (GU) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0","From 6 months post-treatment to 2 years post-treatment",{"measure":59,"description":60,"timeFrame":57},"Grade 2 or Higher Chronic Gastrointestinal Toxicity","Cumulative incidence of grade 2 or higher chronic gastrointestinal (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0",[62,66,70,73,77],{"measure":63,"description":64,"timeFrame":65},"Biochemical Progression-Free Survival","Time from initiation of study treatment to biochemical disease progression or death from any cause.","From initiation of study treatment to 5 years post-treatment",{"measure":67,"description":68,"timeFrame":69},"Acute Gastrointestinal Toxicity","Cumulative incidence of acute gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains.","From end of treatment to 6 months post-treatment",{"measure":71,"description":72,"timeFrame":69},"Acute Genitourinary Toxicity","Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.",{"measure":74,"description":75,"timeFrame":76},"Chronic Gastrointestinal Toxicity","Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains.","From 6 months post-treatment to 5 years post-treatment",{"measure":78,"description":79,"timeFrame":76},"Chronic Genitourinary Toxicity","Incidence of chronic genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.","MALE","19 Years",null,false,{"inclusion":85,"exclusion":86,"raw_text":87},[],[],"Inclusion Criteria:\n\n1. Adults ≥19 years of age\n2. Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered\n3. Prostate gland volume \\\u003C100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT)\n4. PI-RADS 4 or 5 lesion seen on pre-treatment MRI\n5. IPSS\u002FAUA symptom score less than 16\n\nExclusion Criteria:\n\n1. Prior treatment for prostate cancer\n2. Prior solid cancer diagnosis within the last 5 years\n3. Any history of anal or rectal cancer\n4. Any history of invasive carcinoma of the bladder\n5. History of prior circumferential resection of the rectum (such as LAR or APR)",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Fred & Pamela Buffet Cancer Center","Omaha","Nebraska","68198","United States",[99],{"name":100,"role":101,"phone":102,"email":103},"Michael Baine, MD, PhD","CONTACT","(402) 552-2703","mbaine@unmc.edu",{"lat":105,"lon":106},41.25626,-95.94043,[108,112],{"name":109,"role":101,"phone":110,"email":111},"Krishna Gottipati, MS","4025593518","krgottipati@unmc.edu",{"name":113,"role":101,"phone":114,"email":115},"IIT Office Gottipati","4025590963","IITOFFICE@unmc.edu",[117],{"name":100,"affiliation":118,"role":119},"University of Nebraska medicine","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":123,"biomarkers":125},[124],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":127,"prompt_version":136},{"design":128,"status":129,"heading":6,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is a phase 2\u002F3 randomized study involving 186 participants. You would be randomly assigned to one of two treatment groups.","completed","This study is for men with prostate cancer (prostate adenocarcinoma) who are considering a type of radiation therapy called stereotactic body radiotherapy (SBRT). Researchers want to see if boosting the radiation dose to the entire prostate gland or only to the main tumor (dominant intra-prostatic lesion, DIL) makes a difference in side effects. You would receive SBRT, with one of these two boost methods. The main goal is to compare how often patients experience moderate to severe urinary or digestive side effects between 6 months and 2 years after treatment. This study is currently recruiting and plans to enroll 186 participants.","Participants will be followed for up to 5 years after completing treatment.",101,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]