[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618642":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":31,"armGroups":32,"interventions":27,"overallOfficials":27,"centralContacts":27,"locations":36,"responsibleParty":58,"collaborators":60,"id":67,"slug":27,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":27,"enrollmentInfo":76,"targetDuration":27,"studyType":79,"phases":27,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":39,"whyStopped":27,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"The proportion of high-risk prostate cancer patients in which ctDNA-detected minimal residual disease (MRD) exceeds 15%","To determine the proportion of high-risk prostate cancer patients with ctDNA-detected minimal residual disease (MRD) at six weeks postoperatively","From enrollment to 6 weeks postoperatively",{"measure":14,"description":15,"timeFrame":16},"The relation between distant disease-free survival (DDFS) \u003C12 months and minimal residual disease (MRD) positive patients","To determine the risk of early relapse (radiological distant disease-free survival within twelve months following prostatectomy) in patients with and without ctDNA-detected minimal residual disease (MRD)","From enrollment to 12 months postoperatively",[18,21,24],{"measure":19,"description":20,"timeFrame":16},"The relation between distant disease-free survival (DDFS) and 12-week ctDNA-positive patients","To determine the proportion of HR-PCa with ctDNA-detected early relapse at 12 weeks postoperatively",{"measure":22,"description":23,"timeFrame":16},"The relation between ctDNA% and distant disease-free survival (DDFS)","To determine the preoperative ctDNA fractional abundance (ctDNA%) and the prognostic characteristics of ctDNA% related to early relapse and radiological disease-free survival",{"measure":25,"description":26,"timeFrame":16},"The relation between poor prognostic gene signature (TP53 and\u002For PTEN) and\u002For DNA damage repair alterations and distant disease-free survival (DDFS)","To determine whether mutations in TP53, PTEN and DNA damage repair are associated with early distant metastasis-free survival",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","Patients with high-risk prostate cancer",[33],{"label":34,"type":27,"description":35,"interventionNames":27},"High-risk localized prostate cancer or high-risk locally advanced prostate cancer","Included patients will have:\n\n1. High-risk localized prostate cancer, with PSA level \\>20 ng\u002FmL, Gleason score 8-10 (ISUP grade 4\u002F5) at prostate biopsies, or iT3a (based on multi-parametric MRI of the prostate); or\n2. High-risk locally advanced prostate cancer, having any PSA level, any Gleason score\u002FISUP grade, iT3b-4 (based on multi-parametric MRI of the prostate) or iN1 (based on PSMA PET\u002FCT imaging).",[37],{"facility":38,"status":39,"city":40,"state":27,"zip":27,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Prosper Prostate Cancer Clinics","RECRUITING","Nijmegen","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],5.85278,51.8425,{"lat":47,"lon":46},[50,55],{"name":51,"role":52,"phone":53,"phoneExt":27,"email":54},"M.J. van der Doelen, MD, PhD","CONTACT","+31 24 365 8961","m.vanderdoelen@cwz.nl",{"name":56,"role":52,"phone":27,"phoneExt":27,"email":57},"Niven Mehra, MD, PhD","Niven.Mehra@radboudumc.nl",{"type":59,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[61,63,65],{"name":62,"class":6},"Catharina Ziekenhuis Eindhoven",{"name":64,"class":6},"Canisius-Wilhelmina Hospital",{"name":66,"class":6},"Maxima Medical Center","100618642",false,"NCT07334275","Detection of Minimal Residual Disease Post-prostatectomy","Pilot Study for the Detection of Minimal Residual Disease Post-prostatectomy and Early Disease Recurrence in Circulating Tumor DNA to Guide Future Adjuvant Therapy in High-risk Prostate Cancer Patients (MiRaDE)","MiRaDE","Inclusion Criteria:\n\n* Male aged 18 years or older;\n* High-risk prostate cancer, defined as:\n\n  1. High-risk localized prostate cancer, with PSA level \\>20 ng\u002FmL, Gleason score 8-10 (ISUP grade 4\u002F5) at prostate biopsies, or iT3a (based on multi-parametric MRI of the prostate); or\n  2. High-risk locally advanced prostate cancer, having any PSA level, any Gleason score\u002FISUP grade, iT3b-4 (based on multi-parametric MRI of the prostate) or iN1 (based on PSMA PET\u002FCT imaging);\n* Scheduled for robot-assisted radical prostatectomy;\n* Willingness to consent to both patient information sheets regarding tissue and liquid biobanking.\n\nExclusion Criteria:\n\n* Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.","MALE","18 Years",{"count":77,"type":78},50,"ESTIMATED","OBSERVATIONAL","The clinical objective for this pilot study is to determine whether minimal residual disease (MRD) detection in high-risk prostate cancer, utilizing a custom-made prostate-specific circulating tumor DNA (ctDNA) panel, may lead to more optimal prediction of disease recurrence following radical prostatectomy.",[82],"Prostate Cancer",[84,85,86],"Prostate cancer","Prostatectomy","Circulating tumor DNA","2025-12-31",{"date":89,"type":90},"2026-01-12","ACTUAL",{"date":92,"type":90},"2025-09-16",{"date":94,"type":78},"2028-01",{"name":5,"class":6},1]