[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07727473":3,"trial-entities:NCT07727473":125,"trial-summary:NCT07727473":129},{"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":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":50,"sex":76,"minimum_age":77,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":78,"std_ages":93,"locations":96,"central_contacts":115,"overall_officials":119,"references":123,"see_also_links":124},"NCT07727473","2241-2114","Preoperative Semaglutide Prior to Radical Prostatectomy","A Prospective, Open-label, Exploratory Interventional Trial of Preoperative Semaglutide Prior to Radical Prostatectomy for Intermediate-risk Localized Prostate Cancer","NOT_YET_RECRUITING","2029-05","2026-07","2026-07-27","Banner Health","OTHER",false,"In this exploratory, single-arm, nonrandomized trial, the impact of the preoperative utilization of the glucagon-like peptide-1 (GLP-1) receptor agonist (RA) semaglutide prior to radical prostatectomy in participants with intermediate risk prostate cancer will be investigated. Semaglutide will be administered according to the FDA-approved label for chronic weight management and participants will be dosed with a weekly subcutaneous injection. The primary aim of this trial is to explore the tumor biological activity of semaglutide in these participants. The trial will also evaluate the safety and tolerability of this preoperative treatment, along with the impact on physiologic\u002Fmetabolic parameters.",null,[18],"Prostate Cancer",[],"INTERVENTIONAL","TREATMENT",[23],"EARLY_PHASE1",{"count":25,"type":26},20,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Semaglutide 2.4 mg","Semaglutide will be administered as a weekly subcutaneous injection. The dose will be titrated according to the FDA-approved labeling, starting at 0.25 mg once weekly and increasing as tolerated to a target maintenance dose of up to 2.4 mg once weekly. Treatment will continue for 3 to 6 months prior to planned radical prostatectomy.",[33],"Semaglutide Preoperative Treatment",[35,39,43,47],{"measure":36,"description":37,"timeFrame":38},"Change in Caspase-3 (CC3) activation between baseline biopsy and radical prostatectomy specimen","Measured via immunohistochemistry on prostate biopsy tissue and radical prostatectomy specimens; change assessed between pre-treatment biopsy and surgical specimen.","Baseline (pre-treatment biopsy) through radical prostatectomy, assessed up to 6 months",{"measure":40,"description":41,"timeFrame":42},"Change in Ki-67 proliferative index between baseline biopsy and radical prostatectomy specimen","Percentage of Ki-67 expression measured via immunohistochemistry; compared between pre-treatment biopsy and radical prostatectomy specimen.","Baseline through radical prostatectomy, assessed up to 6 months",{"measure":44,"description":45,"timeFrame":46},"Change in Gleason score from biopsy to prostatectomy specimen","Pathologic Gleason Score assessed using the Gleason Grading System (score range 6-10). Higher scores indicate more aggressive prostate cancer pathology.","Baseline biopsy through radical prostatectomy specimen collection, assessed up to 6 months",{"measure":48,"description":49,"timeFrame":46},"Change in Decipher genomic score in prostate tumor tissue","Decipher Genomic Classifier Score (continuous scale ranging from 0 to 1.0). Higher scores indicate greater risk of adverse oncologic outcomes.",[51,55,59,63,66,69,71,73],{"measure":52,"description":53,"timeFrame":54},"Incidence of postoperative complications following radical prostatectomy assessed by Clavien-Dindo classification","Postoperative complications graded using the Clavien-Dindo Classification System (Grade I-V). Higher grades indicate more severe postoperative complications.","30 days and 90 days following radical prostatectomy",{"measure":56,"description":57,"timeFrame":58},"Incidence of Grade 2 or higher adverse events as assessed by CTCAE criteria","Treatment-emergent adverse events graded according to CTCAE criteria; includes events occurring during semaglutide treatment and postoperative follow-up.","From initiation of semaglutide through 90 days post-radical prostatectomy",{"measure":60,"description":61,"timeFrame":62},"Change in body weight","Measured in kilograms and compared between baseline and preoperative assessment.","Baseline through preoperative assessment performed within 14 days prior to radical prostatectomy, assessed up to 6 months",{"measure":64,"description":65,"timeFrame":62},"Change in body mass index (BMI)","BMI (kg\u002Fm²) calculated and compared between baseline and preoperative assessment.",{"measure":67,"description":68,"timeFrame":62},"Change in hemoglobin A1c (HbA1c)","Measured via blood testing and compared between baseline and preoperative assessment.",{"measure":70,"description":68,"timeFrame":62},"Change in c-peptide levels",{"measure":72,"description":68,"timeFrame":62},"Change in high-sensitivity C-reactive protein (hsCRP)",{"measure":74,"description":75,"timeFrame":62},"Change in lipid profile parameters","Includes total cholesterol, LDL, HDL, and triglycerides measured by blood testing and compared between baseline and preoperative assessment.","MALE","18 Years",{"inclusion":79,"exclusion":85,"raw_text":92},[80,81,82,83,84],"Male participants aged ≥18 years","Biopsy-proven intermediate-risk localized prostate cancer per NCCN risk stratification criteria","Planning to undergo radical prostatectomy, and surgical delay of 3-6 months is deemed appropriate by the investigator","Body mass index (BMI) \\>35 kg\u002Fm²","No prior exposure to androgen deprivation therapy or androgen receptor pathway inhibitors",[86,87,88,89,90,91],"Prostate cancer risk classification other than intermediate risk","Hemoglobin A1c (HbA1c) \\>9%","Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)","Baseline gastroparesis, dysphagia, or other significant gastrointestinal disease limiting oral intake","Current or recent (within 12 months) exposure to GLP-1 receptor agonist therapy","Delay of radical prostatectomy by 3-6 months is not deemed advisable by the investigator","Inclusion Criteria:\n\n* Male participants aged ≥18 years\n* Biopsy-proven intermediate-risk localized prostate cancer per NCCN risk stratification criteria\n* Planning to undergo radical prostatectomy, and surgical delay of 3-6 months is deemed appropriate by the investigator\n* Body mass index (BMI) \\>35 kg\u002Fm²\n* No prior exposure to androgen deprivation therapy or androgen receptor pathway inhibitors\n\nExclusion Criteria:\n\n* Prostate cancer risk classification other than intermediate risk\n* Hemoglobin A1c (HbA1c) \\>9%\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)\n* Baseline gastroparesis, dysphagia, or other significant gastrointestinal disease limiting oral intake\n* Current or recent (within 12 months) exposure to GLP-1 receptor agonist therapy\n* Delay of radical prostatectomy by 3-6 months is not deemed advisable by the investigator",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":98,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":112},"Banner MD Anderson Cancer Center at Gateway","Gilbert","Arizona","85234","United States",[104,109],{"name":105,"role":106,"phone":107,"email":108},"Clinical Trials Senior Manager","CONTACT","602-747-3647","nibu.mathew@bannerhealth.com",{"name":110,"role":106,"email":111},"Director, Clinical Trials","klarissa.jones@bannerhealth.com",{"lat":113,"lon":114},33.35283,-111.78903,[116],{"name":117,"role":106,"phone":118,"email":108},"Nibu Mathew","480-256-3425",[120],{"name":121,"affiliation":12,"role":122},"Issac Bowman","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Prostate Carcinoma",[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is a single-arm study, meaning all 20 participants will receive semaglutide. It is an exploratory study, not a randomized trial.","completed","Semaglutide Before Prostate Surgery for Prostate Cancer","This study is looking at how a medicine called semaglutide (often used for weight management) affects prostate cancer before surgery. You might be able to join if you are a man aged 18 or older with intermediate-risk localized prostate cancer, planning to have a radical prostatectomy (surgery to remove the prostate), have a BMI over 35, and have not had certain hormone therapies. Participants will receive weekly injections of semaglutide for 3-6 months before surgery. Researchers will check changes in cancer cells (like Caspase-3 and Ki-67) and Gleason score between your initial biopsy and the prostate removed during surgery to see if semaglutide has an effect. The study is also looking at the safety of semaglutide and its impact on your body's metabolism.","Changes in cancer cells will be assessed up to 6 months after your initial biopsy, which includes the time of your radical prostatectomy.",123,"You would receive weekly subcutaneous (under the skin) injections of semaglutide for 3-6 months before your radical prostatectomy. This involves regular dose adjustments and monitoring.","Not stated in the trial record.",[],"v2"]