[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06907446":3,"trial-entities:NCT06907446":86,"trial-summary:NCT06907446":90},{"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":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":47,"minimum_age":48,"maximum_age":15,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":58,"locations":61,"central_contacts":77,"overall_officials":83,"references":84,"see_also_links":85},"NCT06907446","2262703","Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies","Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted Prostate Biopsies","RECRUITING","2027-12-01","2026-08","2026-08-06","2025-05-01","University of California, Davis","OTHER",null,"To study a novel biopsy needle system for performing transperineal prostate biopsy. Prostate biopsy remains the standard approach for prostate cancer detection. While pre-biopsy MRI allows for targeting of visible lesions, systemic or 'off target' samples are recommended due to the well-recognized risk of undegrading and under sampling with current commercially available needles. The SureCore plus single-use biopsy needle produces a more intact tissue core with a same caliber 18g needle with \\~21% more tissue per core in pre-clinical studies. This research study will determine if a new biopsy needle designed to produce more robust tissue cores per sample can improve detection and characterization of prostate cancer.",[18],"Prostate Cancer",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"NA",{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIAGNOSTIC_TEST","Comparison of Biopsy Needle Types for Prostate Biopsy","Each patient will undergo a standard of care prostate biopsy according to the clinical indication alternating between the SureCore and standard Bard needle",[33],"Single arm study comparing two different needle biopsy systems for prostate biopsy",[35],{"measure":36,"description":37,"timeFrame":38},"Number of patients diagnosed with prostate cancer and histological grade of cancer detected","The primary outcome will evaluate whether cancer is detected on final pathological analysis. This will include the grade of cancer, percentage of core involved, and compare between the two needles.","From prostate biopsy procedure through study completion up to 1 year",[40,43],{"measure":41,"description":42,"timeFrame":38},"Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy","The secondary outcomes will look at the quality of specimen including fragmentation, tortuosity, and spatial orientation of the sample.",{"measure":44,"description":45,"timeFrame":46},"Length of time necessary to diagnose the tissue sample","Time required from collection of specimen to final diagnosis.","Diagnosis within 10 days of the biopsy","MALE","18 Years",false,{"inclusion":51,"exclusion":53,"raw_text":57},[52],"Patient older than age of 18 undergoing prostate biopsy",[54,55,56],"Unable to consent","Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives","Prisoners","Inclusion Criteria:\n\n* Patient older than age of 18 undergoing prostate biopsy\n\nExclusion Criteria:\n\n* Unable to consent\n* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives\n* Prisoners",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"UC Davis Departments of Urologic Oncology","Sacramento","California","95817","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Marc Dall'Era, MD","CONTACT","916-734-2893","mdallera@ucdavis.edu",{"lat":75,"lon":76},38.58157,-121.4944,[78,79],{"name":70,"role":71,"phone":72,"email":73},{"name":80,"role":71,"phone":81,"email":82},"Elisa Lee","916-734-5173","elilee@ucdavis.edu",[],[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Prostate Carcinoma",[],{"nct_id":4,"found":91,"summary":92,"prompt_version":102},true,{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This study involves about 50 men and compares two different biopsy needles during a standard prostate biopsy procedure.","completed","Comparing Biopsy Needles for Prostate Cancer Detection","This study is comparing a new biopsy needle, called SureCore, to the standard needle (Bard) used during a transperineal prostate biopsy. A prostate biopsy is a procedure to remove small tissue samples from the prostate to check for cancer. The SureCore needle is designed to collect more tissue, which might help doctors better detect and understand prostate cancer. You may be able to join if you are a man over 18 years old who is having a prostate biopsy. The study aims to see if the SureCore needle helps diagnose more prostate cancers or provides a clearer picture of the cancer's grade. The current status of this study is unclear.","Participants will be followed from the prostate biopsy procedure through study completion, up to one year.",110,"You would undergo a standard prostate biopsy procedure, where the doctor will alternate between using the SureCore and standard Bard needles. The study will then follow your progress for up to one year after the biopsy.","Not stated in the trial record.",[],"v2"]