[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05558241":3,"trial-entities:NCT05558241":110,"trial-summary:NCT05558241":114},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":55,"locations":58,"central_contacts":103,"overall_officials":104,"references":108,"see_also_links":109},"NCT05558241","HREBA.CC-22-0135","Micro-UltraSound In Cancer - Active Surveillance","Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)","ACTIVE_NOT_RECRUITING","2033-07-30","2026-08","2026-08-26","2022-11-30","University of Alberta","OTHER",false,"This study will compare the two imaging modalities (MRI and micro-ultrasound) during Active Surveillance of prostate cancer (PCa). Progression to clinically significant PCa will be assessed by first taking micro-US targeted samples (while blinded to MRI results), followed by MRI targeted samples, finishing with 12 systematic biopsy cores. The primary goal is to compare microUS to MRI for the detection of ≥GG2 PCa at confirmatory biopsy. This study will also collect blood samples from participants to be used for future biomarker studies.",null,[19],"Prostate Cancer",[21,22],"Active surveillance","micro-ultrasound","INTERVENTIONAL","DIAGNOSTIC",[26],"NA",{"count":28,"type":29},210,"ACTUAL",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","High-resolution micro-ultrasound","In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.",[36],"Combined MRI and micro-ultrasound guided prostate biopsy.",[38],{"measure":39,"description":40,"timeFrame":41},"Cancer upgrading during Active surveillance by micro-ultrasound and MRI","The primary outcome will be detection of ≥Grade Group 2 by each biopsy, technique in combination with the systematic biopsy.","Immediately after biopsy.",[43],{"measure":44,"description":45,"timeFrame":41},"Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.","Secondary outcome will compare each imaged-guided biopsy technique to the standard-of-care 12 core systematic biopsy simultaneously obtained.","MALE","18 Years",{"inclusion":49,"exclusion":51,"raw_text":54},[50],"Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy",[52,53],"Men who cannot undergo a prostate MRI","Men who cannot undergo a prostate biopsy","Inclusion Criteria:\n\n* Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy\n\nExclusion Criteria:\n\n* Men who cannot undergo a prostate MRI\n* Men who cannot undergo a prostate biopsy",[56,57],"ADULT","OLDER_ADULT",[59,68,77,81,89,96],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"University of California Los Angeles, Department of Urology","Los Angeles","California","90095","United States",{"lat":66,"lon":67},34.05223,-118.24368,{"facility":69,"city":70,"state":71,"zip":72,"country":73,"geoPoint":74},"Kipnes Urology Centre - Kaye Edmonton Clinic","Edmonton","Alberta","T6G1Z1","Canada",{"lat":75,"lon":76},53.55014,-113.46871,{"facility":78,"city":79,"state":71,"zip":80,"country":73},"University of British Columbia","Vancouver","V6T 1Z3",{"facility":82,"city":83,"state":84,"zip":85,"country":73,"geoPoint":86},"CIUSSS du Nord-de-L'Ile-De-Montreal","Montreal","Quebec","H3L 1K5",{"lat":87,"lon":88},45.50884,-73.58781,{"facility":90,"city":91,"country":92,"geoPoint":93},"University Hospital Centre Zagreb","Zagreb","Croatia",{"lat":94,"lon":95},45.81444,15.97798,{"facility":97,"city":98,"country":99,"geoPoint":100},"Humanitas","Milan","Italy",{"lat":101,"lon":102},45.46427,9.18951,[],[105],{"name":106,"affiliation":13,"role":107},"Adam Kinnaird, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Prostate Carcinoma",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This interventional study plans to enroll 210 adult men. It compares micro-ultrasound and MRI during a single biopsy session.","completed","Micro-Ultrasound and MRI for Prostate Cancer Active Surveillance","This study is comparing two imaging methods, high-resolution micro-ultrasound (microUS) and MRI, to see which is better at detecting significant prostate cancer in men who are on active surveillance. Active surveillance means closely monitoring prostate cancer that is not immediately treated. You may be eligible if you are an adult man with Gleason Grade Group 1 prostate cancer (a low-risk type) who needs a follow-up biopsy. The main goal is to see if microUS or MRI is more accurate at finding cancer that has progressed to a higher-risk type (Gleason Grade Group 2 or higher) during a confirmatory biopsy. The study plans to enroll 210 participants, but its current status is unclear.","Cancer upgrading is measured immediately after biopsy.",112,"You would undergo a biopsy session where samples are taken using micro-ultrasound, then MRI-guided sampling, followed by 12 systematic biopsy cores. Blood samples will also be collected.","Not stated in the trial record.",[33],"v2"]