[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472951":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":76,"centralContacts":81,"locations":87,"responsibleParty":106,"collaborators":33,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":33,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":33,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":33,"overallStatus":89,"whyStopped":33,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (MRI-guided TULSA)","EXPERIMENTAL","Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and\u002For mpMRI at screening.",[13,14,15,16,17,18,19,20],"Procedure: MRI-Guided Transurethral Ultrasound Ablation","Other: Questionnaire Administration","Procedure: Digital Rectal Examination","Procedure: Cystoscopy","Procedure: Biopsy","Procedure: Bone Scan","Procedure: PSMA PET Scan","Procedure: Multiparametric Magnetic Resonance Imaging",[22,29,34,40,46,53,59,67],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","MRI-Guided Transurethral Ultrasound Ablation","Undergo MRI-Guided TULSA",[9],[28],"MRI-TULSA",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Questionnaire Administration","Ancillary studies",[9],null,{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Digital Rectal Examination","Undergo DRE",[9],[39],"DRE",{"type":23,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Cystoscopy","Undergo cystoscopy",[9],[45],"CS",{"type":23,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Biopsy","Undergo biopsy",[9],[51,52],"Bx","BIOPSY_TYPE",{"type":23,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Bone Scan","Undergo bone scan",[9],[58],"Bone Scintigraphy",{"type":23,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"PSMA PET Scan","Undergo PSMA PET",[9],[64,65,66],"Prostate-specific Membrane Antigen PET","PSMA PET","PSMA-Positron emission tomography",{"type":23,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Multiparametric Magnetic Resonance Imaging","Undergo mpMRI",[9],[72,73,74,75],"MP-MRI","mpMRI","Multi-parametric MRI","Multiparametric MRI",[77],{"name":78,"affiliation":79,"role":80},"David A Woodrum, MD, PhD","Mayo Clinic in Rochester","PRINCIPAL_INVESTIGATOR",[82],{"name":83,"role":84,"phone":85,"phoneExt":33,"email":86},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[88],{"facility":79,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-92.4699,44.02163,{"lat":99,"lon":98},[102,104],{"name":103,"role":84,"phone":85,"phoneExt":33,"email":86},"Clinical Trial Referral Office",{"name":105,"role":80,"phone":33,"phoneExt":33,"email":33},"David A. Woodrum, MD, PhD",{"type":80,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"David A. Woodrum","Principal Investigator","100472951","mri-guided-transurethral-urethral-ultrasound-ablation-for-the-treatment-of-low-to-intermediate-grade-prostate-cancer-100472951",false,"NCT05438563","MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer","Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System","Inclusion Criteria:\n\n* Male\n* Age 45-80 years, with \\> 10 years life expectancy\n* Biopsy-confirmed, NCCN \\[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\\] intermediate-risk prostate cancer\n* Stage =\\\u003C T2c, N0, M0\n* International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy \\[minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category \\>= 3 lesion\\]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline\n* Prostate specific antigen (PSA) =\\\u003C 20 ng\u002FmL reported within 3 months of baseline\n* Treatment naive\n* Planned ablation volume \\\u003C 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline\n\nExclusion Criteria:\n\n* Inability to undergo MRI or general anaesthesia\n* Suspected tumour \\> 30 mm from the prostatic urethra or \\\u003C 14 mm from the prostatic urethra\n* Prostate calcifications \\> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)\n\n  * Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit\n* Unresolved urinary tract infection or prostatitis\n* History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder\n* Artificial urinary sphincter, penile implant or intraprostatic implant\n* Less than 10 years life expectancy\n* Patients who are otherwise not deemed candidates for radical prostatectomy (RP)\n* Inability or unwillingness to provide informed consent\n* History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices","MALE","45 Years","80 Years",{"count":120,"type":121},100,"ESTIMATED","INTERVENTIONAL",[124],"NA","This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.",[127,128,129],"Prostate Carcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","2025-09-03",{"date":132,"type":133},"2025-09-09","ACTUAL",{"date":135,"type":133},"2022-04-06",{"date":137,"type":121},"2027-03-07",{"name":5,"class":6},1]