[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622634":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":33,"locations":43,"responsibleParty":66,"collaborators":20,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":20,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":98,"whyStopped":20,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Micro-Ultrasound Imaging and Biopsy","EXPERIMENTAL","All participants will undergo micro-ultrasound prostate assessment. If a suspicious lesion is identified, targeted biopsy will be performed. All participants will also undergo a 12-core systematic biopsy during the same session.",[13],"Diagnostic Test: Micro-Ultrasound (mUS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Micro-Ultrasound (mUS)","High-frequency micro-ultrasound prostate imaging with real-time lesion assessment. Targeted biopsy of suspicious lesions will be performed when present, along with concurrent systematic 12-core biopsy.",[9],null,[22,26,30],{"name":23,"affiliation":24,"role":25},"Maurice Anidjar, MD, PhD","Jewish General Hospital","STUDY_CHAIR",{"name":27,"affiliation":28,"role":29},"Rafael Sanchez-Salas, MD","McGill Universiy Health Center \u002F\u002F Jewish General Hospital","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":5,"role":32},"Rocio Roldan-Testillano, MD","STUDY_DIRECTOR",[34,39],{"name":31,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","4388285227","Urology","rocio.roldan@mcgill.ca",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"Claudia Covarrubias, MD","(514) 340-8222","claudia.covarrubias@mail.mcgill.ca",[44],{"facility":24,"status":20,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Montreal","Quebec","H3T 1E2","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-73.58781,45.50884,{"lat":54,"lon":53},[57,58,60,62,63,65],{"name":31,"role":35,"phone":36,"phoneExt":20,"email":38},{"name":40,"role":35,"phone":59,"phoneExt":20,"email":42},"(514) 704-9160",{"name":31,"role":61,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"name":27,"role":29,"phone":20,"phoneExt":20,"email":20},{"name":64,"role":29,"phone":20,"phoneExt":20,"email":20},"Maurice Anidjar, MD",{"name":40,"role":61,"phone":20,"phoneExt":20,"email":20},{"type":29,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Rafael Sanchez-Salas","Associate Professor of Urology","100622634","micro-ultrasound-for-detecting-clinically-significant-prostate-cancer-in-active-surveillance-100622634",false,"NCT07386171","Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance","Evaluating Micro-Ultrasound as a Supplemental Imaging Modality for Clinically Significant Prostate Cancer Detection in Men With Negative or Stable Multiparametric MRI on Active Surveillance or at Diagnosis","MUS-AS","Inclusion Criteria:\n\n* Male participants aged 45 to 75 years\n* Localized prostate cancer on active surveillance or newly diagnosed and eligible for active surveillance\n* Negative multiparametric MRI (PI-RADS ≤2) or stable mpMRI findings on surveillance\n* Prior prostate biopsy showing Grade Group 1, or Grade Group 2 (Gleason 3+4) with ≤10% pattern 4\n* PSA ≤15 ng\u002FmL\n* PSA density \\\u003C0.15 ng\u002FmL\u002Fcc\n* Clinical stage ≤T2a\n* Life expectancy \\>10 years\n* Ability to provide written informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Prior definitive treatment for prostate cancer (e.g., radical prostatectomy, radiotherapy)\n* Prior prostate surgery that may affect biopsy or imaging interpretation\n* Contraindication to prostate biopsy\n* Active urinary tract infection or prostatitis\n* Inability to tolerate the biopsy procedure or follow study procedures","MALE","45 Years","75 Years",{"count":81,"type":82},90,"ESTIMATED","INTERVENTIONAL",[85],"NA","Active surveillance is a common approach for men with low-risk or favorable intermediate-risk prostate cancer, aimed at avoiding or delaying treatment while closely monitoring the disease. Multiparametric MRI (mpMRI) is widely used to guide diagnosis and follow-up, but it can miss clinically significant prostate cancer and may be limited by access, cost, and variability in interpretation.\n\nMicro-ultrasound is a high-resolution ultrasound technique that may improve real-time detection of suspicious prostate lesions using a standardized scoring system (PRI-MUS). The purpose of this study is to evaluate the diagnostic performance of micro-ultrasound for detecting clinically significant prostate cancer in men with negative or stable mpMRI findings, either at initial diagnosis or during active surveillance follow-up.\n\nParticipants will undergo micro-ultrasound assessment of the prostate. Areas considered suspicious on micro-ultrasound may be targeted for biopsy, followed by systematic prostate sampling. Biopsy results will be used as the reference standard to determine whether clinically significant prostate cancer is present.\n\nThe study will assess measures such as sensitivity, specificity, and predictive values of micro-ultrasound, as well as procedure-related complications.",[88,89,90],"Prostate Cancer","Active Surveillance for Prostate Cancer","Imaging Techniques",[92,93,94,95,96,97],"Active Surveillance Prostate Cancer","Prostate Cancer Imaging","Micro-ultrasound","Multiparametric MRI","Clinically significant prostate cancer","Targeted-Systematic biopsy","NOT_YET_RECRUITING","2026-01-27",{"date":101,"type":102},"2026-02-04","ACTUAL",{"date":104,"type":82},"2026-03-01",{"date":106,"type":82},"2027-06-01",{"name":5,"class":6},1]