[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426470":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":157,"collaborators":159,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":43,"enrollmentInfo":172,"targetDuration":43,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":183,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Canisius-Wilhelmina Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Testosterone therapy","ACTIVE_COMPARATOR","Daily application of two pump auctions of 16.2mg\u002Fml testosterone gel. Dosage may be altered depending on clinical response",[13],"Drug: Testosterone gel",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo therapy","PLACEBO_COMPARATOR","Daily application of two pump auctions of placebo gel.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Testosterone gel","Topical gel containing testosterone",[9],[27],"Androgel",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Topical gel without active substance",[15],[33],"Placebo gel",[35],{"name":36,"affiliation":5,"role":37},"Diederik Somford, MD, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Joost van Drumpt, MSc","CONTACT","+31243658190",null,"enforce@cwz.nl",[46,61,69,80,91,102,113,124,138,146],{"facility":47,"status":48,"city":49,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Amsterdam UMC location VUmc","RECRUITING","Amsterdam","Netherlands","NL",{"type":53,"coordinates":54},"Point",[55,56],4.88969,52.37403,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":43,"phoneExt":43,"email":43},"André Vis, MD, PhD",{"facility":62,"status":48,"city":49,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Netherlands Cancer Institute",{"type":53,"coordinates":64},[55,56],{"lat":56,"lon":55},[67],{"name":68,"role":41,"phone":43,"phoneExt":43,"email":43},"Pim van Leeuwen, MD, PhD",{"facility":70,"status":48,"city":71,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Rijnstate","Arnhem",{"type":53,"coordinates":73},[74,75],5.91111,51.98,{"lat":75,"lon":74},[78],{"name":79,"role":41,"phone":43,"phoneExt":43,"email":43},"Carl Wijburg, MD, PhD",{"facility":81,"status":48,"city":82,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Catharina Hospital","Eindhoven",{"type":53,"coordinates":84},[85,86],5.47778,51.44083,{"lat":86,"lon":85},[89],{"name":90,"role":41,"phone":43,"phoneExt":43,"email":43},"Robert Hoekstra, MD",{"facility":92,"status":48,"city":93,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Treant","Emmen",{"type":53,"coordinates":95},[96,97],6.90694,52.77917,{"lat":97,"lon":96},[100],{"name":101,"role":41,"phone":43,"phoneExt":43,"email":43},"Luc Roelofs, MD, PhD",{"facility":103,"status":48,"city":104,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Zuyderland","Heerlen",{"type":53,"coordinates":106},[107,108],5.98154,50.88365,{"lat":108,"lon":107},[111],{"name":112,"role":41,"phone":43,"phoneExt":43,"email":43},"Max Bruins, MD, PhD",{"facility":114,"status":48,"city":115,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"St. Antonius Hospital","Nieuwegein",{"type":53,"coordinates":117},[118,119],5.08056,52.02917,{"lat":119,"lon":118},[122],{"name":123,"role":41,"phone":43,"phoneExt":43,"email":43},"Harm van Melick, MD, PhD",{"facility":125,"status":48,"city":126,"state":43,"zip":127,"country":50,"countryCode":51,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Canisius Wilhelmina Ziekenhuis","Nijmegen","6532 SZ",{"type":53,"coordinates":129},[130,131],5.85278,51.8425,{"lat":131,"lon":130},[134],{"name":135,"role":41,"phone":136,"phoneExt":43,"email":137},"Jean-Paul van Basten, MSc, PhD","+31024 365 82 55","j.vanbasten@cwz.nl",{"facility":139,"status":48,"city":126,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Radboud university medical center",{"type":53,"coordinates":141},[130,131],{"lat":131,"lon":130},[144],{"name":145,"role":41,"phone":43,"phoneExt":43,"email":43},"Michiel Sedelaar, MD, PhD",{"facility":147,"status":48,"city":148,"state":43,"zip":43,"country":50,"countryCode":51,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Máxima Medical Centre","Veldhoven",{"type":53,"coordinates":150},[151,152],5.40278,51.41833,{"lat":152,"lon":151},[155],{"name":156,"role":41,"phone":43,"phoneExt":43,"email":43},"Alexander Bellaar Spruyt, MD",{"type":158,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[160],{"name":161,"class":162},"Besins Healthcare","INDUSTRY","100426470","phase-3-impact-of-peri-operative-testosterone-levels-on-oncological-and-functional-outcomes-in-radical-prostatectomy-100426470",false,"NCT04833426","Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy","ENFORCE","Inclusion criteria\n\n1. Men aged 18 years or older\n2. Histologically confirmed prostate cancer\n3. Radical prostatectomy performed as primary treatment\n4. At least one-sided nerve-sparing procedure performed\n5. Non-metastatic disease (cN0M0) based on the use of nomograms or imaging\n6. Undetectable PSA level (\\\u003C0.1 µg\u002Fl or unmeasurable according to local protocol) within six weeks following RP\n7. A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain\n8. Testosterone deficiency, defined as total testosterone \\\u003C8 nmol\u002FL, or total testosterone between 8-12 nmol\u002FL with free testosterone \\\u003C225 pmol\u002FL, measured on two separate occasions, with normal or elevated luteinising hormone (LH)\n\nExclusion criteria\n\n1. Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)\n2. Previous use of testosterone therapy for any reason\n3. Pathological stage pT3b or pT4 in the RP specimen\n4. Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen\n5. Presence of metastatic lymph nodes if pelvic lymph node dissection was performed\n6. History of male breast cancer or liver tumour\n7. Uncontrolled hypertension\n8. General contraindications for TRT\n9. Allergy for components in TRT agent or placebo\n10. Use of vitamin K antagonists\n11. Body mass index (BMI) \\>30 kg\u002Fm²","MALE","18 Years",{"count":173,"type":174},140,"ESTIMATED","INTERVENTIONAL",[177],"PHASE3","Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).",[180,181,182],"Prostatic Neoplasms","Hypogonadism","Testosterone Deficiency",[184,185,181,186],"Prostate cancer","Prostatectomy","Testosterone deficiency","2025-05-01",{"date":189,"type":190},"2025-05-02","ACTUAL",{"date":192,"type":190},"2022-12-12",{"date":194,"type":174},"2029-12",{"name":5,"class":6},10]