[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100373717":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":21,"armGroups":17,"interventions":17,"overallOfficials":17,"centralContacts":17,"locations":22,"responsibleParty":42,"collaborators":45,"id":51,"slug":17,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":17,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":17,"studyType":63,"phases":17,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":25,"whyStopped":17,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"I.M. Sechenov First Moscow State Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"cancer progression","Number of patients who had one of the following signs of cancer progression: new lesion on DRE proved by biopsy, or histological upgrade on follow-up biopsy, or involvement of more than 33% cores on follow-up biopsy","5 years",[14],{"measure":15,"description":16,"timeFrame":12},"surgical treatment due to infravesical obstruction by BPH","Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","Men with low risk prostate cancer, who gave informed consent to undergo active surveillance and to participate in this study, and had no previous treatment of prostate cancer or surgery at the prostate.",[23],{"facility":24,"status":25,"city":26,"state":17,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Institute for Urology and Reproductive Health, Sechenov University.","RECRUITING","Moscow","119991","Russia","RU",{"type":31,"coordinates":32},"Point",[33,34],37.61781,55.75204,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":17,"email":41},"Dmitry Enikeev, MD, PhD","CONTACT","+7 925 517 79 26","enikeev-dv@1msmu.ru",{"type":43,"investigatorFullName":38,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Deputy director for Research, Institute for Urology and Reproductive Health",[46,49],{"name":47,"class":48},"Moscow Regional Research and Clinical Institute (MONIKI)","OTHER_GOV",{"name":50,"class":6},"Pirogov Russian National Research Medical University","100373717",false,"NCT04146077","Active Surveillance for Low Risk Prostate Cancer","Active Surveillance Methodology for Low Risk Prostate Cancer","Inclusion Criteria:\n\n* prostate adenocarcinoma verified by at least 12 core biopsy\n* patient must understand the sense of research, agree to participate and sign a form of agreement\n* low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA\\\u003C10 ng\u002Fml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6)\n* not more than 33% cores with adenocarcinoma\n\nExclusion Criteria:\n\n* previous treatment of prostate cancer\n* other prostatic malignant neoplasms\n* other oncological diseases\n* treatment with 5-alfa-reductase inhibitors\n* patient's refuse to continue study\n* patient's desire to begin treatment","MALE","50 Years","75 Years",{"count":61,"type":62},100,"ESTIMATED","OBSERVATIONAL","An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.",[66,67],"Prostate Cancer","Prostate Adenocarcinoma",[69,70,71],"prostate cancer","active surveillance","low oncological risk","2021-07-21",{"date":74,"type":75},"2021-07-22","ACTUAL",{"date":77,"type":75},"2019-10-01",{"date":79,"type":62},"2026-10",{"name":5,"class":6},1]