[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spanish Oncology Genito-Urinary Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100571738","observational-study-of-the-effectiveness-of-funded-drugs-for-genitourinary-tumors-100571738",false,"NCT06724159","Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.","PRINCIS Study (\"Public Health Clinical Research Project\"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.","SOGUG-PRINCIS","Inclusion Criteria:\n\n* Patients ≥18 years old.\n* Patients granting the ICF unless exemption or exceptions mentioned below.\n* Histological diagnosis of malignant neoplasia originating in the genitourinary system: kidney, renal pelvis, ureter, bladder, prostate, testicle and germinal tissue of other locations, urethra, penis, or seminal vesicles.\n* Patients have started treatment with medications whose positive resolution of financing by the Spanish National Health System for the aforementioned tumors has been after January 1, 2023.\n* Patients have started treatment after the official publication of the positive resolution of financing of the drug under study by the National Health System. This restriction is intended to avoid interference of the study with the marketing authorization processes by the European Medicines Agency, and price and reimbursement negotiations by the Spanish health authorities.\n* Patients have received treatment at the participating center.\n\nExclusion Criteria:\n\n* Patients previously treated at another centre who have subsequently been referred to one of the participating centres. In this case, the patient will be included in the centre where treatment was started, or in the second centre if the first is not part of this study.\n* Patients who do not meet any of the inclusion criteria.\n* Evidence of an express objection by the subject or his\u002Fher legal representative to participate in the study.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","3 Years","OBSERVATIONAL","SOGUG-PRINCIS is a retrospective (regarding patient inclusion) and prospective follow-up, epidemiological, non-interventional, non-blinded, non-randomized, multicenter, national observational study with drugs. This study will collect data from patients with genitourinary tumors to analyze the effectiveness under routine clinical practice conditions of drugs recently approved for funding in the Spanish National Health System.\n\nIn all cases, the decision to start treatment will be made prior to and independently of participation in the study, which will be limited to subsequently collecting the data necessary to assess the objectives of the study.\n\nThis study will serve as a registry for genitourinary cancers. Every time a new drug will be authorized, a new subproject with a primary endpoint will be opened to recruitment. The substudy will try to validate with real-world data the endpoints reported in the phase III clinical trials that led to the marketin authorization.",[26],"Genitourinary Cancers",[28,29,30,31,32,33],"Urothelial carcinoma","Prostate adenocarcinoma","Renal carcinoma","Darolutamida","Nivolumab","Enfortumab Vedotin","RECRUITING","2026-02-13",{"date":37,"type":38},"2026-02-17","ACTUAL",{"date":40,"type":38},"2024-12-13",{"date":42,"type":21},"2027-12",{"name":44,"class":45},"Spanish Oncology Genito-Urinary Group","OTHER",84,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100555404","phase-2-erdafitinib-monotherapy-or-in-combination-with-cetrelimab-in-muscle-invasive-bladder-cancer-patients-with-fibroblast-growth-factor-receptor-fgfr--gene-alterations-100555404","NCT06511648","Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations","A Phase 2, Open-label, Multi-centre, Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib (ERDA) Monotherapy and Erdafitinib (ERDA) and Cetrelimab (CET) Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer (MIBC) Whose Tumours Express Fibroblast Growth Factor Receptor ( FGFR ) Gene Alterations","SOGUG-NEOWIN","Inclusion Criteria:\n\n1. Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study.\n2. Histologically confirmed diagnosis of MIBC (Stage T2-4a N0\u002FN1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no later than 3 months prior to start the screening visit.\n3. Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n6. Decline or ineligible (\"unfit\") for cisplatin-based chemotherapy\n7. Presence of a selected FGFR alteration on analysis of tumour biopsy\n8. Adequate organ function\n9. No other malignancy\n10. Willingness to avoid pregnancy or fathering children\n\nExclusion Criteria:\n\n1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer.\n2. Has tumour with any neuroendocrine or small cell component.\n3. Patients who are not considered fit for cystectomy or reject cystectomy.\n4. Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1\u002FPDL1 )systemic therapy.\n5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer",{"count":56,"type":21},90,"INTERVENTIONAL",[59],"PHASE2","Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR )gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy.",[62],"Muscle-invasive Bladder Cancer",[28],"2025-12-12",{"date":66,"type":38},"2025-12-19",{"date":68,"type":38},"2023-03-07",{"date":70,"type":21},"2029-10",{"name":44,"class":45},23,""]