Clinical Research Directory
Browse clinical research sites, groups, and studies.
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
Sponsor: Spanish Oncology Genito-Urinary Group
Summary
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.
Official title: PRINCIS Study ("Public Health Clinical Research Project"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2024-12-13
Completion Date
2027-12
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
darolutamide
Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice
Nivolumab monotherapy
Adjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice
enfortumab vedotin
Following the posology and administration details of its marketing authorization and standard clinical practice
Locations (84)
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, Spain
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Hospital Universitario Torrecárdenas
Almería, Andalusia, Spain
Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
Hospital Universitario Clínico San Cecilio
Granada, Andalusia, Spain
Hospital Universitario Virgen a de las Nieves
Granada, Andalusia, Spain
Hospital Universitario de Jaén
Jaén, Andalusia, Spain
Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Andalusia, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Quirón Salud Sagrado Corazón de Sevilla
Seville, Andalusia, Spain
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain
Hospital Universitario Virgen de Valme
Seville, Andalusia, Spain
Hospital Universitario San Jorge
Huesca, Aragon, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Hospital General Mateu Orfila
Mahón, Balearic Islands, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Cruces
Barakaldo, Basque Country, Spain
Hospital Universitario Basurto
Bilbao, Basque Country, Spain
OSI Donostialdea - Onkologikoa
Donostia / San Sebastian, Basque Country, Spain
Hospital Galdakao-Usansolo Ospitalea
Galdakao, Basque Country, Spain
Hospital Universitario de Álava - Txagorritxu
Vitoria-Gasteiz, Basque Country, Spain
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Complejo Hospitalario de Palencia
Palencia, Castille and León, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital General de Segovia
Segovia, Castille and León, Spain
Hospital Clínico Universitario de Valladolid (HCUV)
Valladolid, Castille and León, Spain
Complejo Hospitalario Zamora
Zamora, Castille and León, Spain
Hospital Universitario Mancha Centro
Alcázar de San Juan, Castille-La Mancha, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Castille-La Mancha, Spain
Hospital Virgen de la Luz
Cuenca, Castille-La Mancha, Spain
Hospital Universitario de Guadalajara
Guadalajara, Castille-La Mancha, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, Catalonia, Spain
Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Catalonia, Spain
Hospital Universitari Parc Taulí, Sabadell
Sabadell, Catalonia, Spain
Hospital Universitari General de Catalunya
Sant Cugat Del Vallés, Catalonia, Spain
Hospital Universitario de Badajoz
Badajoz, Extremadura, Spain
Hospital San Pedro de Alcántara
Cáceres, Extremadura, Spain
Hospital Universitario de A Coruña (CHUAC)
A Coruña, Galicia, Spain
Centro Oncológico de Galicia
A Coruña, Galicia, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, Galicia, Spain
Hospital Universitario Lucus Augusti
Lugo, Galicia, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, Spain
Hospital Clínico Universitario de Santiago ~ CHUS
Santiago de Compostela, Galicia, Spain
Hospital Álvaro Cunqueiro
Vigo, Galicia, Spain
Hospital Universitario San Pedro
Logroño, La Rioja, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Central de la Defensa Gómez Ulla
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Infanta Sofía
San Sebastián, Madrid, Spain
Hospital Universitario Infanta Leonor
Vallecas, Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Virgen de los Lirios
Alcoy, Valencia, Spain
Hospital Universitario de la Ribera
Alzira, Valencia, Spain
Hospital Universitario del Vinalopó
Elche, Valencia, Spain
Hospital General de Requena
Requena, Valencia, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Universitario de Torrevieja
Torrevieja, Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Consorcio Hospital General Universitario de València
Valencia, Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, Spain
Hospital Universitario Doctor Peset
Valencia, Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Hospital Marina Baixa
Villajoyosa, Valencia, Spain
Hospital Lluis Alcanyís de Xàtiva
Xàtiva, Valencia, Spain
Hospital Universitario de Toledo
Toledo, Spain