[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05792722":3,"trial-entities:NCT05792722":134,"trial-summary:NCT05792722":138},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":93,"locations":96,"central_contacts":126,"overall_officials":129,"references":132,"see_also_links":133},"NCT05792722","IRB00345549","Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy","A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer","RECRUITING","2029-07","2025-11","2025-11-18","2023-10-25","Johns Hopkins University","OTHER",true,"The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.","The purpose of this study is to determine if prostate capsule-sparing cystectomy improves functional outcomes without compromising the oncologic outcomes in patients with bladder cancer. The comparison arm will be patients undergoing nerve-sparing radical cystectomy. Participants will be randomized to receive either a nerve-sparing radical cystectomy or a prostate capsule-sparing radical cystectomy. Patients will be monitored following standard of care guidelines every 3-months post-operatively up to and including 24 months post-operatively. As part of standard of care post-operative follow-up patients will have routine history and physical exams, urine cytology, urine culture, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), and Prostate Specific Antigen (PSA). Standard of Care diagnostic imaging will also occur. The Sexual Health Inventory for Men (SHIM) Questionnaire will be given to patients 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post-operatively. To measure urinary function in patients who receive orthotopic neobladder, the Validated Pad Questionnaire will be given 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post operatively. Adverse Events will be monitored in both groups as defined by the CTCAE 5.0 guidelines.",[19],"Bladder Cancer",[21,22,23,24],"Radical Cystectomy","Prostate Capsule-Sparing Cystectomy","Nerve-Sparing Cystectomy","Male","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},70,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"PROCEDURE","Prostate capsule-sparing radical cystectomy","Patients randomized to this arm will receive the prostate capsule-sparing surgery performed in the form of standard simple prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.",[38],"Prostate Capsule-Sparing Radical Cystectomy",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Nerve sparing radical cystectomy","Patients randomized to this arm will receive the nerve-sparing surgery will be performed in the form of the standard nerve-sparing radical prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.",[43],"Nerve-Sparing Radical Cystectomy",[45],{"measure":46,"description":47,"timeFrame":48},"Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)","Comparison of functional outcomes focusing on preservation of erectile function in patients undergoing cystectomy for bladder cancer. Functional Outcomes will be measured by the Sexual Health Inventory for Men (SHIM) Questionnaire. The Sexual Health Inventory for Men defines the following ranges of Erectile Dysfunction (ED): 1-7 is Severe ED, 8-11 Moderate ED, 12-16 Mild to Moderate ED, and 17 to 21 is Mild ED.","Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op",[50,54,57,60,64],{"measure":51,"description":52,"timeFrame":53},"Change in urinary function in patients with orthotopic neobladder as assessed by the Validated Pad Questionnaire","Urinary function in patient with orthotopic neobladder urinary diversions measured using the Validated Pad Questionnaire. The Validated Pad questionnaire will be used to determine the percentage of patients utilizing 1 to 2 pads versus 2 or more pads for night and day, respectively.","Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively , 24-months post-op",{"measure":55,"description":56,"timeFrame":48},"Change in overall patient survival","Comparing the overall survival of patients in both arms of the study",{"measure":58,"description":59,"timeFrame":48},"Change in disease specific status","Comparing the status of disease specific in both arms of the study",{"measure":61,"description":62,"timeFrame":63},"Soft tissue surgical margin rate as assessed by pathology","Pathologists will examine the soft tissue surgical margin rate to determine positive or negative soft tissue surgical margin.","Up to 4-weeks after surgical intervention",{"measure":65,"description":66,"timeFrame":67},"Safety as assessed by adverse events experienced by study participants","Comparing the differences in adverse events (grades 2-5) as experienced by the participants of in each study arm. The grading of adverse events are defined by the CTCAE 5.0 guidelines.","Up to 24-months post-operative","MALE","18 Years",null,false,{"inclusion":73,"exclusion":79,"raw_text":92},[74,75,76,77,78],"Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy","Variant histologies of bladder cancer permitted","Neoadjuvant therapy permitted","Age \\> 18 years old","Ability to understand and willingness to sign a written informed consent document",[80,81,82,83,84,85,86,87,88,89,90,91],"Patients that are not candidates for cystectomy","Moderate to severe erectile dysfunction with SHIM score \\\u003C17","Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra","Prior pelvic radiation","Confirmed prostate cancer:","Patients with abnormal Digital rectal exam (DRE), PSA \\>3 or Prostate Imaging Reporting \\& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer","Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:","≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age","≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y","≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age","≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed","Patients with Lynch syndrome","Inclusion Criteria:\n\n* Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy\n* Variant histologies of bladder cancer permitted\n* Neoadjuvant therapy permitted\n* Age \\> 18 years old\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients that are not candidates for cystectomy\n* Moderate to severe erectile dysfunction with SHIM score \\\u003C17\n* Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra\n* Prior pelvic radiation\n* Confirmed prostate cancer:\n* Patients with abnormal Digital rectal exam (DRE), PSA \\>3 or Prostate Imaging Reporting \\& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer\n* Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:\n* ≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age\n* ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y\n* ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age\n* ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed\n* Patients with Lynch syndrome",[94,95],"ADULT","OLDER_ADULT",[97,115],{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":112},"Sibley Memorial Hospital","Washington D.C.","District of Columbia","20016","United States",[104,109],{"name":105,"role":106,"phone":107,"email":108},"Armine Smith, MD","CONTACT","202-660-5561","asmit165@jhmi.edu",{"name":110,"role":106,"email":111},"Domani Rodriguez","drodri59@jh.edu",{"lat":113,"lon":114},38.89511,-77.03637,{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":102,"contacts":120,"geoPoint":123},"Johns Hopkins Hospital","Baltimore","Maryland","21287",[121,122],{"name":105,"role":106,"phone":107,"email":108},{"name":110,"role":106,"email":111},{"lat":124,"lon":125},39.29038,-76.61219,[127,128],{"name":105,"role":106,"phone":107,"email":108},{"name":110,"role":106,"email":111},[130],{"name":105,"affiliation":13,"role":131},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":135,"biomarkers":137},[136],"Bladder Carcinoma",[],{"nct_id":4,"found":15,"summary":139,"prompt_version":149},{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This is an interventional study planning to enroll 70 men. Participants will be randomly assigned to receive either prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy.","completed","Evaluating Prostate-sparing Radical Cystectomy for Bladder Cancer","This study is for men with bladder cancer who need a radical cystectomy (surgery to remove the bladder). It compares two surgical approaches: prostate capsule-sparing radical cystectomy and nerve-sparing radical cystectomy. The main goal is to see if the prostate capsule-sparing surgery can improve functional outcomes, like erectile function, without affecting cancer control. You would be randomly assigned to one of the two surgery groups. Researchers will track your erectile function using a questionnaire and monitor your overall health and safety for up to two years after surgery. This study is currently recruiting men over 18 with confirmed bladder cancer.","Participants will be followed for up to 24 months after surgery, with assessments of functional outcomes and safety.",100,"You would have surgery and then follow-up appointments every three months for up to 24 months. You would also complete questionnaires about erectile function and, if applicable, urinary function at various times.","Not stated in the trial record.",[35],"v2"]