[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654331":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":65,"studyPopulation":59,"armGroups":66,"interventions":79,"overallOfficials":89,"centralContacts":94,"locations":103,"responsibleParty":117,"collaborators":59,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":59,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":59,"studyType":133,"phases":134,"briefSummary":137,"conditions":138,"keywords":59,"overallStatus":140,"whyStopped":59,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"The Methodist Hospital Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":49},[9,13,16,20,24],{"measure":10,"description":11,"timeFrame":12},"Participant Accrural","Number of participants enrolled in the study","Through study completion, an average of 1 year",{"measure":14,"description":15,"timeFrame":12},"Protocol Adherence","Proportion of participants who complete study procedures according to protocol requirements.",{"measure":17,"description":18,"timeFrame":19},"Successful Completion of Intraprostatic Injection","Number of participants who successfully receive the assigned intraprostatic study injection.","At time of surgery",{"measure":21,"description":22,"timeFrame":23},"Incidence of Adverse Events","Incidence, severity, seriousness, and relationship of adverse events associated with intraprostatic administration of onabotulinumtoxinA or placebo.","From study injection through 36 months of follow-up.",{"measure":25,"description":26,"timeFrame":27},"Successful Completion of Planned Radical Prostatectomy","Proportion of participants who undergo planned radical prostatectomy following study intervention without study-related cancellation or unacceptable delay.","Within 6 to 8 weeks after intraprostatic injection.",[29,33,36,39,42,45],{"measure":30,"description":31,"timeFrame":32},"Gleason Score at Radical Prostatectomy","Comparison of Gleason score determined from radical prostatectomy specimens between treatment arms.\n\nGleason Score determined from radical prostatectomy specimens. Gleason Scores range from 6 to 10, with higher scores indicating more aggressive prostate cancer.","At radical prostatectomy (6 to 8 weeks after study injection).",{"measure":34,"description":35,"timeFrame":32},"Perineural Invasion","Presence and extent of perineural invasion identified in radical prostatectomy specimens.",{"measure":37,"description":38,"timeFrame":32},"Stromogenic Component","Assessment of stromogenic component in radical prostatectomy specimens.",{"measure":40,"description":41,"timeFrame":32},"Tumor Size","Tumor size measured in radical prostatectomy specimens. The measurement will be recorded in centimeters (cm).",{"measure":43,"description":44,"timeFrame":32},"Positive Surgical Margin Status","Proportion of participants with positive surgical margins following radical prostatectomy.",{"measure":46,"description":47,"timeFrame":48},"Postoperative Prostate-Specific Antigen (PSA)","Serum PSA levels following radical prostatectomy.","6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.",[50],{"measure":51,"description":52,"timeFrame":53},"Time to Biochemical Recurrence","Time from radical prostatectomy to biochemical recurrence as defined by postoperative PSA progression.","Up to 36 months after radical prostatectomy.",{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":59,"timePerspective":59,"maskingInfo":60},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to receive either a single intraprostatic injection of onabotulinumtoxinA (50 units) or placebo (normal saline) administered 6 to 8 weeks prior to radical prostatectomy. Participants remain in their assigned treatment group throughout the study, and outcomes are compared between parallel treatment arms.","TREATMENT",null,{"masking":61,"maskingDescription":62,"whoMasked":63},"SINGLE","Participant will not know if they are receiving Botox or placebo, they will remain blinded.",[64],"PARTICIPANT","High-risk localized prostate cancer is associated with a substantial risk of adverse pathological features and disease recurrence despite definitive treatment with radical prostatectomy. Emerging evidence suggests that neural signaling within the prostate tumor microenvironment contributes to tumor growth, progression, and treatment resistance. OnabotulinumtoxinA (BOTOX®), a neurotoxin that blocks acetylcholine release, has demonstrated biological effects in prostate tissue and may provide a novel approach to modulating tumor-associated neural pathways.\n\nThis single-center, prospective, randomized, single-blind, placebo-controlled pilot study will enroll 30 men with high-risk or very-high-risk localized prostate adenocarcinoma who are scheduled to undergo radical prostatectomy. Participants will be randomized in a 1:1 ratio to receive either a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or an equivalent-volume normal saline placebo 6 to 8 weeks prior to surgery. Participants will remain blinded to treatment assignment.\n\nThe primary objective is to evaluate study feasibility and safety, including participant accrual, protocol adherence, successful completion of intraprostatic injection and planned surgery, and the incidence and severity of adverse events. Secondary objectives include evaluation of pathological outcomes at prostatectomy, including Gleason score, perineural invasion, stromogenic component, tumor burden, pathological stage, and surgical margin status. Early postoperative PSA outcomes will also be assessed. Exploratory analyses will evaluate time to biochemical recurrence following radical prostatectomy.\n\nThis pilot study is not powered to demonstrate clinical efficacy. Instead, it is designed to establish the safety and feasibility of neoadjuvant intraprostatic onabotulinumtoxinA and generate preliminary biological and pathological data to support future studies investigating neural modulation as a therapeutic strategy in prostate cancer.",[67,73],{"label":68,"type":69,"description":70,"interventionNames":71},"Botox","EXPERIMENTAL","A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.",[72],"Drug: OnabotulinumtoxinA (BOTOX®)",{"label":74,"type":75,"description":76,"interventionNames":77},"Placebo","PLACEBO_COMPARATOR","A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline placebo administered in an identical volume and injection pattern 6 to 8 weeks prior to radical prostatectomy.",[78],"Other: Normal Saline Placebo",[80,85],{"type":81,"name":82,"description":70,"armGroupLabels":83,"otherNames":84},"DRUG","OnabotulinumtoxinA (BOTOX®)",[68],[68],{"type":6,"name":86,"description":87,"armGroupLabels":88,"otherNames":59},"Normal Saline Placebo","Participants randomized to the placebo arm will receive a single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline administered in an identical volume and injection pattern as the active treatment arm, 6 to 8 weeks prior to planned radical prostatectomy.",[74],[90],{"name":91,"affiliation":92,"role":93},"Brian Miles, MD","Houston Methodist Urology, Houston Methodist Research Institute","PRINCIPAL_INVESTIGATOR",[95,100],{"name":96,"role":97,"phone":98,"phoneExt":59,"email":99},"Vivian MacDonnell, MD","CONTACT","7134928703","vmmacdonnell@houstonmethodist.org",{"name":91,"role":97,"phone":101,"phoneExt":59,"email":102},"7138170870","bjmiles@houstonmethodist.org",[104],{"facility":105,"status":59,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":59},"Houston Methodist","Houston","Texas","77030","United States","US",{"type":112,"coordinates":113},"Point",[114,115],-95.36327,29.76328,{"lat":115,"lon":114},{"type":93,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"Brian Miles","Principal Investigator","100654331","phase-1-neoadjuvant-intraprostatic-onabotulinumtoxina-before-radical-prostatectomy-for-high-risk-localized-prostate-cancer-100654331",false,"NCT07796490","Neoadjuvant Intraprostatic OnabotulinumtoxinA Before Radical Prostatectomy for High-Risk Localized Prostate Cancer","A Pilot Randomized, Single Blind, Placebo Controlled Study of Neoadjuvant Intraprostatic OnabotulinumtoxinA Prior to Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer","Inclusion Criteria:\n\n* Male, ≥ 45 years\n* Histologically confirmed prostate adenocarcinoma\n* Gleason score ≥8 on biopsy\n* Candidate for and scheduled to undergo RALP for primary treatment\n* ECOG 0-2\n* Able to read, speak, and understand English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Prior prostate cancer therapy (radiation, ADT, chemotherapy)\n* Metastatic disease\n* Known hypersensitivity to botulinum toxin\n* Neuromuscular disorders (e.g., myasthenia gravis)\n* Active infection, coagulopathy, or contraindication to transperineal injection\n* Medications significantly affecting neuromuscular transmission (clinically relevant)\n* Any condition compromising safety or protocol compliance","MALE","45 Years","80 Years",{"count":131,"type":132},30,"ESTIMATED","INTERVENTIONAL",[135,136],"PHASE1","PHASE2","This pilot randomized, single-blind, placebo-controlled study evaluates the feasibility, safety, and preliminary biological activity of neoadjuvant intraprostatic onabotulinumtoxinA (BOTOX®) administered before radical prostatectomy in men with high-risk localized prostate cancer. Thirty participants will be randomized 1:1 to receive a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or placebo 6 to 8 weeks before surgery. Outcomes include feasibility metrics, safety, adverse events, pathological findings at prostatectomy, and postoperative prostate-specific antigen (PSA) levels",[139],"Prostate Cancer","NOT_YET_RECRUITING","2026-08-31",{"date":143,"type":144},"2026-09-02","ACTUAL",{"date":146,"type":132},"2026-11-01",{"date":148,"type":132},"2029-11-01",{"name":5,"class":6},1]