[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Canisius-Wilhelmina Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27,28],"Prostatic Neoplasms","Hypogonadism","Testosterone Deficiency",[30,31,27,32],"Prostate cancer","Prostatectomy","Testosterone deficiency","RECRUITING","2025-05-01",{"date":36,"type":37},"2025-05-02","ACTUAL",{"date":39,"type":37},"2022-12-12",{"date":41,"type":20},"2029-12",{"name":43,"class":44},"Canisius-Wilhelmina Hospital","OTHER",10,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100439325","dutch-national-randomized-study-psma-petct-as-a-triage-tool-for-pelvic-lymph-node-dissection-in-prostatectomy-patients-100439325","NCT05000827","Dutch National Randomized Study: PSMA-PET\u002FCT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients","Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET\u002FCT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients","PSMA-SELECT","Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of the prostate\n* Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram \\>5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)\n* Suitable for robot-assisted ePLND and RARP\n* Mentally competent and understanding of benefits and potential burden of the study\n* Written informed consent\n* No known allergies for PSMA tracer.\n\nExclusion Criteria:\n\n* History of prior diagnosed or treated PCa\n* Known concomitant malignancies (except Basal Cell Carcinoma of the skin)\n* Unwillingness or inability to undergo PSMA PET\u002FCT and\u002For ePLND and RARP\n* PSMA non-avid PCa (local tumor activity)\n* Presence of distant metastasis (M1)",{"count":55,"type":20},706,[57],"NA","To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET\u002FCT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk \\>5%.",[60,61,62],"Prostate Cancer Metastatic","Prostate Cancer","Lymph Node Metastases","2025-02-19",{"date":65,"type":37},"2025-02-21",{"date":67,"type":37},"2021-07-28",{"date":69,"type":20},"2026-08-31",{"name":43,"class":44},1,""]