[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546722":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":41,"responsibleParty":115,"collaborators":119,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":24,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":93,"whyStopped":24,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,13,16],{"label":9,"type":6,"description":10,"interventionNames":11},"Low Risk Cohort","Participants are placed into their arm after appropriate genetic testing has been conducted to determine their risk.",[12],"Other: Polygenic Risk Score (PRS)",{"label":14,"type":6,"description":10,"interventionNames":15},"Intermediate Risk Cohort",[12],{"label":17,"type":6,"description":10,"interventionNames":18},"High Risk Cohort",[12],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Polygenic Risk Score (PRS)","Participants will be put into PRS cohorts based on their genetic data.\n\nAll participants enrolled into the study will receive a PSA screening test and an mpMRI, regardless of their polygenic risk score.",[17,14,9],null,[26,29],{"name":27,"affiliation":5,"role":28},"Adam S Kibel, MD, MHCM","STUDY_CHAIR",{"name":30,"affiliation":31,"role":28},"Peter Pinto, MD","National Cancer Institute (NCI)",[33,37],{"name":27,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","(617) 525-7697","akibel@bwh.harvard.edu",{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},"Daniella Furtado","(617) 525-8782","dfurtado1@bwh.harvard.edu",[42,62,81,91,107],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Howard University Hospital","NOT_YET_RECRUITING","Washington D.C.","District of Columbia","20060","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-77.03637,38.89511,{"lat":54,"lon":53},[57,59],{"name":58,"role":34,"phone":24,"phoneExt":24,"email":24},"Pamela Coleman, MD",{"name":60,"role":61,"phone":24,"phoneExt":24,"email":24},"Tamaro S Hudson, PhD, MPH","SUB_INVESTIGATOR",{"facility":63,"status":44,"city":64,"state":65,"zip":66,"country":48,"countryCode":49,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"National Cancer Institute","Bethesda","Maryland","20814",{"type":51,"coordinates":68},[69,70],-77.10026,38.98067,{"lat":70,"lon":69},[73,77,79],{"name":74,"role":34,"phone":75,"phoneExt":24,"email":76},"Peter A Pinto, MD","204-858-7200","pintop@mail.nih.gov",{"name":78,"role":61,"phone":24,"phoneExt":24,"email":24},"Ismail B Turkbey, MD",{"name":80,"role":61,"phone":24,"phoneExt":24,"email":24},"Peter L Choyke, MD, FACR",{"facility":82,"status":44,"city":64,"state":65,"zip":66,"country":48,"countryCode":49,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Walter Reed National Military Medical Center",{"type":51,"coordinates":84},[69,70],{"lat":70,"lon":69},[87],{"name":88,"role":34,"phone":89,"phoneExt":24,"email":90},"Gregory T Chesnut, MD","301-319-2900","gregory.chesnut@usuhs.edu",{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":48,"countryCode":49,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Massachusetts General Hospital","RECRUITING","Boston","Massachusetts","02114",{"type":51,"coordinates":98},[99,100],-71.05977,42.35843,{"lat":100,"lon":99},[103],{"name":104,"role":34,"phone":105,"phoneExt":24,"email":106},"Keyan Salari, MD, PhD","857-238-3838","ksalari@mgh.harvard.edu",{"facility":5,"status":93,"city":94,"state":95,"zip":108,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":111,"contacts":112},"02155",{"type":51,"coordinates":110},[99,100],{"lat":100,"lon":99},[113],{"name":27,"role":34,"phone":114,"phoneExt":24,"email":36},"617-525-7697",{"type":116,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Adam S. Kibel, MD","Chair, Department of Urology, Brigham Health & Dana-Farber Cancer Institute; DiNovi Family Distinguished Chair in Urology, Brigham and Women's Hospital; Elliott Carr Cutler Professor of Surgery, Harvard Medical School",[120],{"name":31,"class":121},"NIH","100546722","polygenic-risk-stratification-combined-with-mpmri-to-identify-clinically-relevant-prostate-cancer-100546722",false,"NCT06398639","Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer","PRS","Inclusion Criteria:\n\n* They must have the ability to understand and the willingness to sign a written information consent document.\n* Estimated life expectancy of greater than 10 years.\n* No history of prostate cancer.\n* Participants must be between 40-69 years of age. This is the age at which screening for prostate cancer is recommended. This is due to younger patients not being at risk for the disease and older patients not benefiting from diagnosis.\n* No biopsy for prostate cancer within the past 5 years.\n* No prostate MRI within the past 5 years.\n\nExclusion Criteria:\n\n* Unwillingness to sign the informed consent form.\n* Contraindication to biopsy such as uncorrectable bleeding or coagulation disorder.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit the safety of a biopsy and\u002For surgery.\n* Unable to undergo an MRI.",true,"MALE","40 Years","69 Years",{"count":134,"type":135},1500,"ESTIMATED","INTERVENTIONAL",[138],"NA","The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer.\n\nThe main questions it aims to answer are:\n\n* If genetic data related to prostate cancer used with MRI can identify higher-grade, potentially fatal prostate cancer\n* What age a MRI is useful clinically for prostate cancer screening\n* If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers\n\nParticipants will:\n\n* Get a prostate specific antigen (PSA) blood test\n* Get an mpMRI\n* Get the results of their genetic data to determine if they are considered high-, intermediate-, or low-risk for prostate cancer based on the trials genetic testing\n* Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI",[141,142],"Prostate Cancer","Polygenic Risk Score",[142,141,144,145],"Prostate Cancer Screening","Multiparametric MRI","2025-11-06",{"date":148,"type":149},"2025-11-10","ACTUAL",{"date":151,"type":149},"2024-05-07",{"date":153,"type":135},"2030-04-30",{"name":117,"class":6},5]