[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525062":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":53,"centralContacts":58,"locations":66,"responsibleParty":93,"collaborators":95,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":10,"enrollmentInfo":106,"targetDuration":10,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":10,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Turku University Hospital","OTHER_GOV",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"suspicion",null,"Inclusion criteria for the suspicion cohort include clinical suspicion for PCa and indication for PCA diagnostics based on any of the following: 1) elevated PSA (\\>2.5 ng\u002Fml), 2) palpable prostate tumor\u002Fnodule, 3) image finding suggestive of PCa.\n\nThe suspicion cohort will include a total of 300 subjects who will undergo PCa diagnostics including prostate MRI, and transrectal ultrasound (TRUS) guided prostate biopsies. After the diagnostic procedures all subjects are categorized to one of the following groups: 1) subject without PCa, 2) subject with clinically non-significant PCa (ISUP grade 1\u002FGleason 3+3), 3) clinically significant PCa (ISUP grade \\>1\u002F\\>Gleason 3+3).\n\nBased on the outcome of the PCa diagnostics and planned clinical treatment, subjects may be eligible to other cohorts as well.",[13,14],"Other: MRI scan and laboratory visit","Procedure: Prostate biopsies",{"label":16,"type":10,"description":17,"interventionNames":18},"cancer (radical prostatectomy) cohort","Inclusion criteria for the cancer cohort include clinically significant prostate cancer planned to be treated with radical prostatectomy with or without pelvic lymph node dissection. The cancer cohort will include a total of 50 subjects.",[19],"Procedure: Radical prostatectomy and blood, urine and tissue sampling",{"label":21,"type":10,"description":22,"interventionNames":23},"benign\u002FTURP-cohort","Inclusion criteria for the benign (TURP) cohort includes benign prostate hyperplasia (BPH) planned to be treated with transurethral resection of the prostate (TURP). The benign\u002FTURP-cohort will include a total of 50 subjects.",[24],"Procedure: TURP and blood, urine and tissue sampling",{"label":26,"type":10,"description":27,"interventionNames":28},"benign\u002Fcystectomy","Inclusion criteria for the benign\u002Fcystectomy cohort includes bladder cancer planned to be treated with removal of the urinary bladder and prostate (cystoprostatectomy). The benign\u002Fcystectomy cohort will include a total of 25 subjects.",[29],"Procedure: Radical cystoprostatectomy and blood, urine and tissue sampling",[31,36,41,45,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"OTHER","MRI scan and laboratory visit","Prostate MRI scan is performed according to the protocol used in earlier studies (PMID 31158230). In addition to the PCa diagnostics, the scan will include abdominal imaging to body composition analysis (visceral and subcutaneous fat and psoas muscle). Baseline blood and urine samples are collected in Turku University Hospital laboratory.",[9],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"PROCEDURE","Prostate biopsies","The visit follows routine outpatient clinic protocol. The results from MRI and laboratory findings are discussed and the potential benefits and harms from prostate biopsies are evaluated. After a mutual decision, prostate biopsies are performed.",[9],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"Radical prostatectomy and blood, urine and tissue sampling","Baseline blood and urine samples are collected at the time of surgery. Robotic assisted laparoscopic prostatectomy (RALP) is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.",[16],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"TURP and blood, urine and tissue sampling","Baseline blood and urine samples are collected the time of surgery. TURP is performed according to normal protocol. Routine diagnostic histopathological procedures will be followed in the department of pathology. Additionally, tissue samples (a total of 10 resection chips) will be collected for study analyses. Due to the study, no additional tissue samples are removed, i.e. study samples are from the tissues removed as clinically indicated.",[21],{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Radical cystoprostatectomy and blood, urine and tissue sampling","Baseline blood and urine samples are collected at the time of surgery. Radical cystoprostatectomy is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.",[26],[54],{"name":55,"affiliation":56,"role":57},"Peter J. Bostrom, MD, PhD","Turku University Hospital and University of Turku","PRINCIPAL_INVESTIGATOR",[59,63],{"name":55,"role":60,"phone":61,"phoneExt":10,"email":62},"CONTACT","+358-2-3135925","peter.bostrom@tyks.fi",{"name":64,"role":60,"phone":10,"phoneExt":10,"email":65},"Tarja Lamminen, PhD","tarja.lamminen@tyks.fi",[67,86],{"facility":68,"status":69,"city":70,"state":10,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"University of Turku","RECRUITING","Turku","20100","Finland","FI",{"type":75,"coordinates":76},"Point",[77,78],22.26869,60.45148,{"lat":78,"lon":77},[81,83],{"name":82,"role":60,"phone":61,"phoneExt":10,"email":62},"Peter J Bostrom, MD, PhD",{"name":84,"role":85,"phone":10,"phoneExt":10,"email":10},"Antti Salminen, MD","SUB_INVESTIGATOR",{"facility":5,"status":69,"city":70,"state":10,"zip":10,"country":72,"countryCode":73,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},{"type":75,"coordinates":88},[77,78],{"lat":78,"lon":77},[91],{"name":92,"role":57,"phone":10,"phoneExt":10,"email":10},"Peter J. Boström, MD, PhD",{"type":94,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[96],{"name":68,"class":32},"100525062","prostate-metabolism-cancer-risk-and-gut-microbiota-100525062",false,"NCT06116851","Prostate Metabolism, Cancer Risk and Gut Microbiota","PROMIC","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Ability and stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* inability to comply with study procedures or unwillingness to participate in the study.","MALE","18 Years",{"count":107,"type":108},300,"ESTIMATED","OBSERVATIONAL","This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.",[112,113],"Prostate Cancer","Prostate Hyperplasia","2023-10-30",{"date":116,"type":117},"2023-11-03","ACTUAL",{"date":119,"type":117},"2022-06-01",{"date":121,"type":108},"2026-09-15",{"name":5,"class":6},2]