[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565003":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":91,"collaborators":93,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":10,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Institute of Cancer Research, United Kingdom","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1",null,"People with a prostate aged 40-55 years of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry to undergo genetic testing using the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening.",[13],"Genetic: The i4i PRODICT® test.",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2","Those classified as high-risk due to either falling within the high polygenic risk score category, and\u002For having a rare variant in a gene in the i4i PRODICT® test will be offered a hospital clinic appointment at the Royal Marsden Hospital to discuss prostate cancer screening.",[13,18,19,20],"Other: Prostate cancer screening","Procedure: MRI Scan","Procedure: Prostate Biopsy",[22,27,31,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"GENETIC","The i4i PRODICT® test.","The i4i PRODICT® test combining both common and rare genetic variants into one saliva-based DNA test to estimate a person's future risk of prostate cancer. This test will be offered to all participants in Part 1 of the study. Participants will be classified into high-risk or population risk based on the results of the i4i PRODICT® test. Those classified as high-risk due to either falling within the high polygenic risk score category, and\u002For having a rare variant in a gene in the test will be offered targeted prostate cancer screening.",[9,15],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Prostate cancer screening","Prostate cancer screening in the form of PSA testing will be offered to all participants identified as high risk from the i4i PRODICT® test for three years in order to track development of cancer in the future.",[15],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"PROCEDURE","MRI Scan","MRI scan will be offered to participants identified in the high-risk category of the i4i PRODICT® test depending on their PSA test results. Where PSA is above age-specific threshold (\\>2.5ug\u002FL for people with prostates (PwPs) aged 40-50 years and \\>3.5ug\u002FL for PwPs aged 50-55 years), those with raised PSA levels will be referred for multiparametric MRI at The Royal Marsden Hospital.",[15],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"Prostate Biopsy","Transperineal prostate biopsy under local anaesthetic will be offered to to participants identified in the high-risk category of the i4i PRODICT® test depending on their MRI results. Where a lesion is visible on MRI (defined as a PIRAD score ≥3) onward referral will be made for a transperineal targeted prostate biopsy (or current gold standard NHS practice).",[15],[41],{"name":42,"affiliation":43,"role":44},"Rosalind A Eeles, FRCP; FRCR","The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Eva McGrowder, PhD","CONTACT","+44 208 722 4483","Eva.McGrowder@icr.ac.uk",{"name":52,"role":48,"phone":49,"phoneExt":10,"email":53},"Elizabeth K Bancroft, PhD","elizabeth.bancroft@rmh.nhs.uk",[55,73,85],{"facility":43,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Sutton","Surrey","SM2 5PT","United Kingdom","UK",{"type":63,"coordinates":64},"Point",[65,66],-0.2,51.35,{"lat":66,"lon":65},[69,71,72],{"name":42,"role":48,"phone":49,"phoneExt":10,"email":70},"Ros.Eeles@icr.ac.uk",{"name":52,"role":48,"phone":49,"phoneExt":10,"email":53},{"name":42,"role":44,"phone":10,"phoneExt":10,"email":10},{"facility":74,"status":56,"city":75,"state":10,"zip":76,"country":60,"countryCode":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"The Royal Marsden Hospital","London","SW3 6JJ",{"type":63,"coordinates":78},[79,80],-0.12574,51.50853,{"lat":80,"lon":79},[83],{"name":10,"role":48,"phone":10,"phoneExt":10,"email":84},"prostate.research@rmh.nhs.uk",{"facility":74,"status":56,"city":57,"state":10,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},{"type":63,"coordinates":87},[65,66],{"lat":66,"lon":65},[90],{"name":10,"role":48,"phone":10,"phoneExt":10,"email":84},{"type":92,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[94,96],{"name":95,"class":6},"Royal Marsden NHS Foundation Trust",{"name":97,"class":6},"Imperial College London","100565003","the-i4i-prodict-study-evaluation-of-the-i4i-prodict-test-in-different-ethnic-groups-the-i4i-prodict-study-100565003",false,"NCT06636526","The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups (The i4i PRODICT® Study).","The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups.","Inclusion Criteria:\n\n* People with a prostate\\* (PwP). \\*People with a prostate is defined as people born male.\n* Aged 40 to 55 years.\n* People of either (i) Black African\u002FBlack African-Caribbean; (ii) White European; or (iii) South Asian or East Asian ancestry. These are defined as individuals with 4 grandparents of the same ancestry.\n* Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Previous diagnosis of prostate cancer.\n* People of mixed ancestry\n* Previous diagnosis of cancer with a life-expectancy of less than five years.\n* Negative prostate biopsy within one year before recruitment.\n* Any significant psychological conditions that may be worsened or exacerbated by participation in the study.",true,"MALE","40 Years","55 Years",{"count":110,"type":111},1000,"ESTIMATED","OBSERVATIONAL","The i4i PRODICT® study has been developed to investigate the uptake and acceptability of the i4i PRODICT® test which combines both common and rare genetic changes (genetic variants) into one saliva-based DNA test to estimate a person's future risk of prostate cancer (PrCa) in people of varying ethnicities.",[115],"Prostate Cancer",[115,28,117,118,119],"Polygenic risk score","PSA","Genetic Predisposition","2026-02-02",{"date":122,"type":123},"2026-02-04","ACTUAL",{"date":125,"type":123},"2025-06-02",{"date":127,"type":111},"2033-01-06",{"name":5,"class":6},3]