Tracks how funded drugs work for genitourinary cancers in routine care
Collects data on darolutamide, nivolumab and enfortumab vedotin in adults with genitourinary cancers.
Plain-language title generated from the registry record
Registry title: Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
Key facts
- Where
- A Coruña, Albacete, Alcalá de Henares, Alcázar de San Juan, Alcoy, Alicante, Almería, Alzira, Badajoz, Barakaldo, Barcelona, Bilbao, Burgos, Cáceres, Ciudad Real, Córdoba, Cuenca, Donostia / San Sebastian, El Palmar, Elche, Ferrol, Galdakao, Getafe, Gijón, Granada, Guadalajara, Huesca, Jaén, Jerez de la Frontera, Las Palmas de Gran Canaria, Leganés, Logroño, Lugo, Madrid, Mahón, Majadahonda, Málaga, Manresa, Móstoles, Murcia, Ourense, Oviedo, Palencia, Palma de Mallorca, Pamplona, Pozuelo de Alarcón, Requena, Sabadell, Sagunto, Salamanca, San Sebastián, Sant Cugat del Vallès, Santiago de Compostela, Segovia, Seville, Toledo, Torrevieja, Valencia, Valladolid, Vallecas, Vigo, Villajoyosa, Vitoria-Gasteiz, Xàtiva, Zamora, and Zaragoza, SpainSee the 84 sites
Where in Spain
- Centro Oncologico de GaliciaA Coruña, SpainTaking people
- Hospital Universitario de A Coruña (CHUAC)A Coruña, SpainTaking people
- Complejo Hospitalario Universitario de AlbaceteAlbacete, SpainTaking people
- Hospital Universitario Principe de AsturiasAlcalá de Henares, SpainTaking people
- Hospital Universitario Mancha CentroAlcázar de San Juan, SpainTaking people
- Hospital Virgen de Los LiriosAlcoy, SpainTaking people
- Hospital General Universitario de AlicanteAlicante, SpainTaking people
- Hospital Universitario TorrecárdenasAlmería, SpainTaking people
- Hospital Universitario de La RiberaAlzira, SpainTaking people
- Hospital Universitario de BadajozBadajoz, SpainTaking people
- Hospital Universitario de CrucesBarakaldo, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario BasurtoBilbao, SpainTaking people
- Hospital Universitario De BurgosBurgos, SpainTaking people
- Hospital San Pedro De AlcántaraCáceres, SpainTaking people
- Hospital General Universitario de Ciudad RealCiudad Real, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Hospital Virgen de la LuzCuenca, SpainTaking people
- OSI Donostialdea - OnkologikoaDonostia / San Sebastian, SpainTaking people
- Hospital Universitario Virgen de la ArrixacaEl Palmar, SpainTaking people
- Hospital Universitario del VinalopoElche, SpainTaking people
- Complejo Hospitalario Universitario de FerrolFerrol, SpainTaking people
- Hospital Galdakao-Usansolo OspitaleaGaldakao, SpainTaking people
- Hospital Universitario de GetafeGetafe, SpainTaking people
- Hospital Universitario de CabueñesGijón, SpainTaking people
- Hospital Universitario Clínico San CecilioGranada, SpainTaking people
- Hospital Universitario Virgen a de las NievesGranada, SpainTaking people
- Hospital Universitario de GuadalajaraGuadalajara, SpainTaking people
- Hospital Universitario San JorgeHuesca, SpainTaking people
- Hospital Universitario de JaénJaén, SpainTaking people
- Hospital Universitario Jerez De La FronteraJerez de la Frontera, SpainTaking people
- Hospital Materno Infantil de Gran CanariaLas Palmas de Gran Canaria, SpainTaking people
- Hospital Universitario Severo OchoaLeganés, SpainTaking people
- Hospital Universitario San PedroLogroño, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Hospital Central de la Defensa Gómez UllaMadrid, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital General Mateu OrfilaMahón, SpainTaking people
- Hospital Universitario Puerta de HierroMajadahonda, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- ALTHAIA, Xarxa Assistencial Universitaria de Manresa.Manresa, SpainNot yet recruiting
- Hospital Universitario De MóstolesMóstoles, SpainTaking people
- Hospital General Universitario Morales MeseguerMurcia, SpainTaking people
- Complexo Hospitalario Universitario de OurenseOurense, SpainTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainTaking people
- Complejo Hospitalario de PalenciaPalencia, SpainTaking people
- Hospital Son EspasesPalma de Mallorca, SpainTaking people
- Hospital Universitario Son LlatzerPalma de Mallorca, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
- Hospital General de RequenaRequena, SpainTaking people
- Hospital Universitari Parc Taulí, SabadellSabadell, SpainTaking people
- Hospital de SaguntoSagunto, SpainTaking people
- Complejo Asistencial Universitario de SalamancaSalamanca, SpainTaking people
- Hospital Universitario Infanta SofíaSan Sebastián, SpainTaking people
- Hospital Universitari General de CatalunyaSant Cugat del Vallès, SpainTaking people
- Hospital Clínico Universitario de Santiago CHUSSantiago de Compostela, SpainTaking people
- Hospital General de SegoviaSegovia, SpainTaking people
- Hospital Quirón Salud Sagrado Corazón de SevillaSeville, SpainNot yet recruiting
- Hospital Universitario Virgen de ValmeSeville, SpainTaking people
- Hospital Universitario Virgen del RocioSeville, SpainTaking people
- Hospital Universitario Virgen MacarenaSeville, SpainTaking people
- Hospital Universitario de ToledoToledo, SpainTaking people
- Hospital Universitario de TorreviejaTorrevieja, SpainTaking people
- Consorcio Hospital General Universitario de ValenciaValencia, SpainTaking people
- Hospital Arnau de VilanovaValencia, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- Hospital Universitario Doctor PesetValencia, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
- Instituto Valenciano de OncologiaValencia, SpainTaking people
- Hospital Clínico Universitario de Valladolid (HCUV)Valladolid, SpainTaking people
- Hospital Universitario Infanta LeonorVallecas, SpainTaking people
- Hospital Alvaro CunqueiroVigo, SpainTaking people
- Hospital Marina BaixaVillajoyosa, SpainTaking people
- Hospital Universitario de Álava - TxagorritxuVitoria-Gasteiz, SpainTaking people
- Hospital Lluis Alcanyís de XàtivaXàtiva, SpainTaking people
- Complejo Hospitalario ZamoraZamora, SpainTaking people
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpainTaking people
- Hospital Universitario Miguel ServetZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Spanish Oncology Genito-Urinary Group
- Trial code
- NCT06724159
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
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 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.
In 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.
This 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.
Inclusion: Patients ≥18 years old; Patients granting the ICF unless exemption or exceptions mentioned below; 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; 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; 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; Patients have received treatment at the participating center.
Exclusion: 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; Patients who do not meet any of the inclusion criteria; Evidence of an express objection by the subject or his/her legal representative to participate in the study.