[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501531":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":37,"responsibleParty":101,"collaborators":103,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":10,"enrollmentInfo":117,"targetDuration":120,"studyType":121,"phases":10,"briefSummary":122,"conditions":123,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Institute of Cancer Research, United Kingdom","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm",null,"Men diagnosed with low-grade PrCa undergoing Active Surveillance and are not known to have an increased genetic risk for PrCa e.g. Men without high-risk mutations or high polygenic risk score (PRS).\n\nMen diagnosed with PrCa suitable for Active Surveillance who wish to continue follow up at collaborating hospitals will be offered enrolment in collection and monitoring of various biological samples. These men will act as a control group, as they do not have a known higher genetic risk of PrCa. The control group will have genetic analysis carried out on provided saliva or blood samples. Their family history will be captured. They will be genotyped using the latest technology and at a minimum have PRS testing done.\n\nMen may be moved out of the control arm and into the high-risk arm, if identified at a higher genetic risk or as having a strong family history of PrCa for the purposes of the analysis. Any clinically significant genetic results will be discussed with the participants.",[13],"Other: Active Surveillance",{"label":15,"type":10,"description":16,"interventionNames":17},"High-risk Arm","Men who have been diagnosed with low grade PrCa and are undergoing active surveillance who are at genetically higher risk of PrCa defined as:\n\n1. Men of any ancestry with a family history defined as at least one first degree (or second degree if through the female line) relative with PrCa diagnosed at \\\u003C70 years (diagnosis verified).\n2. Men of Black African or Caribbean ancestry irrespective of family history\n3. Men of any ancestry known to carry a mutation in a high-risk gene thought to cause a higher risk of prostate cancer.\n4. Men of ancestry with a high genetic risk (common and\u002For rare variants) for prostate cancer resulting in relative risk (RR) of ≥2.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Active Surveillance","Active surveillance (AS) is an accepted management strategy for men diagnosed with low risk PrCa, generally defined as PSA \\\u003C10ng\u002Fml and Gleason score of ≤6 and clinical stage T1 to T2a. Occasionally, a minority of men with Gleason 3+4 disease are included, though majority of those included in AS studies have Gleason 3+3 disease or less.\n\nMen in AS studies have repeated biopsies based on various criteria including PSA velocity, repeat biopsy at set time points and change noted on digital rectal examination (DRE), biopsy or MRI imaging. Progression of disease has been defined in various ways in different studies, generally, using criteria of Gleason upgrade to greater than Gleason 3+3, evidence of Gleason 4 or Gleason 5 disease, \\>50% involvement of any one biopsy core, and greater than 2 cores positive on repeat biopsy. Percentages of men on AS who have upgrade on repeat biopsy have been found to be 19-34%; this may differ in our cohort of men with increased genetic risk for PrCa.",[9,15],[24],{"name":25,"affiliation":26,"role":27},"Ros A Eeles, FRCP, FRFR","Institute of Cancer Research and Royal Marsden Hospital","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Eva McGrowder, PhD","CONTACT","02087224483","eva.mcgrowder@icr.ac.uk",{"name":35,"role":31,"phone":32,"phoneExt":10,"email":36},"Elizabeth K Bancroft, PhD","elizabeth.bancroft@icr.ac.uk",[38,58,75,93],{"facility":26,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Sutton","Surrey","SM2 5PT","United Kingdom","UK",{"type":46,"coordinates":47},"Point",[48,49],-0.2,51.35,{"lat":49,"lon":48},[52,56],{"name":53,"role":31,"phone":54,"phoneExt":10,"email":55},"Rosalind A Eeles, FRCP FRFR","02086613642","rosalind.eeles@icr.ac.uk",{"name":57,"role":27,"phone":10,"phoneExt":10,"email":10},"Rosalind A Eeles, FRCP FRCR",{"facility":59,"status":60,"city":61,"state":10,"zip":62,"country":43,"countryCode":44,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"North Bristol NHS Trust","NOT_YET_RECRUITING","Bristol","BS10 5NB",{"type":46,"coordinates":64},[65,66],-2.59665,51.45523,{"lat":66,"lon":65},[69,73],{"name":70,"role":31,"phone":71,"phoneExt":10,"email":72},"Urology Research Team","0117 4148109","urologyresearch@nbt.nhs.uk",{"name":74,"role":27,"phone":10,"phoneExt":10,"email":10},"Jonathan Aning, FRCS",{"facility":76,"status":39,"city":77,"state":10,"zip":78,"country":43,"countryCode":44,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"The Royal Marsden Hospital","London","SW3 6JJ",{"type":46,"coordinates":80},[81,82],-0.12574,51.50853,{"lat":82,"lon":81},[85,88,91],{"name":30,"role":31,"phone":86,"phoneExt":10,"email":87},"020 8722 4483","Eva.McGrowder@icr.ac.uk",{"name":89,"role":31,"phone":86,"phoneExt":10,"email":90},"Elizabeth Bancroft, PhD","Elizabeth.Bancroft@rmh.nhs.uk",{"name":92,"role":27,"phone":10,"phoneExt":10,"email":10},"Ros Eeles, FRCR",{"facility":76,"status":39,"city":40,"state":10,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},{"type":46,"coordinates":95},[48,49],{"lat":49,"lon":48},[98,99,100],{"name":30,"role":31,"phone":86,"phoneExt":10,"email":87},{"name":89,"role":31,"phone":86,"phoneExt":10,"email":90},{"name":92,"role":27,"phone":10,"phoneExt":10,"email":10},{"type":102,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[104,106],{"name":105,"class":6},"Royal Marsden NHS Foundation Trust",{"name":59,"class":6},"100501531","the-active-surveillance-study-100501531",false,"NCT05810467","The Active Surveillance Study","Active Surveillance Study for Prostate Cancer Management for Men at Higher Genetic Risk Compared With Men at No Known Higher Genetic Risk.","AS","Inclusion Criteria\n\n* Men ≥18 years old under the care of an Active Surveillance clinic.\n* Known diagnosis of PrCa, deemed suitable for Active surveillance at multi-disciplinary meeting (MDT).\n* Men at genetically higher PrCa risk who are either:\n\n  (1) Men of any ancestry with a positive family history of PrCa defined as:\n* Having a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \\\u003C70 years\n* Having two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \\\u003C70 years\n* Having three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age\n\nOr (2) Men of Black African or Black African-Caribbean ancestry defined as:\n\n* Both parents and all 4 grandparents from that origin Or (3) Men of any ancestry with a pathogenic mutation in a gene thought to cause a higher risk of prostate cancer: (including BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in appendix A) Or (4) Men of any ancestry with a high genetic risk (common and\u002For rare variants) for PrCa resulting in a RR of ≥2 of PrCa\n* Men of any ancestry with no known high risk genetic factors who have been diagnosed with low grade PrCa and deemed suitable for Active Surveillance at multi-disciplinary meeting (control group) as defined in the 4 criteria above.\n* Who performance status 0-2\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* No PrCa diagnosis\n* PrCa diagnosis that is not deemed suitable for active surveillance at multi-disciplinary meeting\n* Any significant psychological conditions that may be worsened or exacerbated by participation in the study","MALE","18 Years",{"count":118,"type":119},200,"ESTIMATED","5 Years","OBSERVATIONAL","The Active Surveillance study is a prospective study developed to look at the association of biomarkers with PrCa presentation and progression among men on Active Surveillance and stratify it by their genetic risk. This study will also investigate the incidence and progression by differing genetic risks.",[124],"Prostate Cancer","2026-02-02",{"date":127,"type":128},"2026-02-04","ACTUAL",{"date":130,"type":128},"2023-08-22",{"date":132,"type":119},"2027-12",{"name":5,"class":6},4]