Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Last updated: February 13, 2026
Sponsor: Spanish Oncology Genito-Urinary Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Treatment

enfortumab vedotin

Nivolumab monotherapy

darolutamide

Clinical Study ID

NCT06724159
SOGUG-PRINCIS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥18 years old.

  • Patients granting the ICF unless exemption or exceptions mentioned below.

  • Histological diagnosis of malignant neoplasia originating in the genitourinarysystem: kidney, renal pelvis, ureter, bladder, prostate, testicle and germinaltissue of other locations, urethra, penis, or seminal vesicles.

  • Patients have started treatment with medications whose positive resolution offinancing by the Spanish National Health System for the aforementioned tumors hasbeen after January 1, 2023.

  • Patients have started treatment after the official publication of the positiveresolution of financing of the drug under study by the National Health System. Thisrestriction is intended to avoid interference of the study with the marketingauthorization processes by the European Medicines Agency, and price andreimbursement negotiations by the Spanish health authorities.

  • Patients have received treatment at the participating center.

Exclusion

Exclusion Criteria:

  • Patients previously treated at another centre who have subsequently been referred toone of the participating centres. In this case, the patient will be included in thecentre where treatment was started, or in the second centre if the first is not partof 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 toparticipate in the study.

Study Design

Total Participants: 500
Treatment Group(s): 3
Primary Treatment: enfortumab vedotin
Phase:
Study Start date:
December 13, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Complejo Hospitalario Universitario de Albacete

    Albacete 2522258, Albacete 02006
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante 2521978, Alicante 03010
    Spain

    Active - Recruiting

  • Hospital Universitario Torrecárdenas

    Almería, Andalucia 04009
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba, Andalucia 14004
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Cecilio

    Granada, Andalucia 18007
    Spain

    Site Not Available

  • Hospital Universitario Virgen a de las Nieves

    Granada, Andalucia 18014
    Spain

    Active - Recruiting

  • Hospital Universitario de Jaén

    Jaén, Andalucia 23007
    Spain

    Site Not Available

  • Hospital Universitario Jerez de la Frontera

    Jerez de la Frontera, Andalucia 11407
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalucia 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, Andalucia 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Valme

    Sevilla, Andalucia 41014
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, Andalucia 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Torrecárdenas

    Almería 2521886, Andalusia 2593109 04009
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba 2519240, Andalusia 2593109 14004
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada 2517117, Andalusia 2593109 18007
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen a de las Nieves

    Granada 2517117, Andalusia 2593109 18014
    Spain

    Active - Recruiting

  • Hospital Universitario de Jaén

    Jaén 2516395, Andalusia 2593109 23007
    Spain

    Active - Recruiting

  • Hospital Universitario Jerez de la Frontera

    Jerez de la Frontera 2516326, Andalusia 2593109 11407
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga 2514256, Andalusia 2593109 29010
    Spain

    Active - Recruiting

  • Hospital Quirón Salud Sagrado Corazón de Sevilla

    Seville 2510911, Andalusia 2593109 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Seville 2510911, Andalusia 2593109 41009
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de Valme

    Seville 2510911, Andalusia 2593109 41014
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville 2510911, Andalusia 2593109 41013
    Spain

    Active - Recruiting

  • Hospital Universitario San Jorge

    Huesca 3120514, Aragon 3336899 22004
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza 3104324, Aragon 3336899 50009
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza 3104324, Aragon 3336899 50009
    Spain

    Active - Recruiting

  • Hospital Universitario San Jorge

    Huesca, Aragón 22004
    Spain

    Site Not Available

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Aragón 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragón 50009
    Spain

    Site Not Available

  • Hospital Universitario de Cabueñes

    Gijón, Asturias 33394
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital General Mateu Orfila

    MAhón, Baleares 07703
    Spain

    Site Not Available

  • Hospital Son Espases

    Palma de Mallorca, Baleares 07120
    Spain

    Active - Recruiting

  • Hospital Universitario Son Llàtzer

    Palma de Mallorca, Baleares 07198
    Spain

    Site Not Available

  • Hospital General Mateu Orfila

    Maó 2514301, Balearic Islands 2521383 07703
    Spain

    Active - Recruiting

  • Hospital Son Espases

    Palma de Mallorca 2512989, Balearic Islands 2521383 07120
    Spain

    Active - Recruiting

  • Hospital Universitario Son Llàtzer

    Palma de Mallorca 2512989, Balearic Islands 2521383 07198
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo 3109453, Basque Country 3336903 48903
    Spain

    Active - Recruiting

  • Hospital Universitario Basurto

    Bilbao 3128026, Basque Country 3336903 48013
    Spain

    Active - Recruiting

  • OSI Donostialdea - Onkologikoa

    Donostia / San Sebastian 3110044, Basque Country 3336903 20014
    Spain

    Active - Recruiting

  • Hospital Galdakao-Usansolo Ospitalea

    Galdakao 3121751, Basque Country 3336903 48960
    Spain

    Active - Recruiting

  • Hospital Universitario de Álava - Txagorritxu

    Vitoria-Gasteiz 3104499, Basque Country 3336903 01009
    Spain

    Active - Recruiting

  • Hospital Materno Infantil de Gran Canaria

    Las Palmas de Gran Canaria 2515270, Canary Islands 2593110 35016
    Spain

    Active - Recruiting

  • Hospital Universitario Mancha Centro

    Alcázar de San Juan, Castilla la Mancha 13600
    Spain

    Site Not Available

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, Castilla la Mancha 13005
    Spain

    Site Not Available

  • Hospital Virgen de la Luz

    Cuenca, Castilla la Mancha 16002
    Spain

    Site Not Available

  • Hospital Universitario de Guadalajara

    Guadalajara, Castilla la Mancha 19002
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos, Castilla y Leon 09006
    Spain

    Site Not Available

  • Complejo Hospitalario de Palencia

    Palencia, Castilla y Leon 34004
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, Castilla y Leon 37007
    Spain

    Site Not Available

  • Hospital General de Segovia

    Segovia, Castilla y Leon 40002
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid (HCUV)

    Valladolid, Castilla y Leon 47003
    Spain

    Site Not Available

  • Complejo Hospitalario Zamora

    Zamora, Castilla y Leon 49022
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos 3127461, Castille and León 3336900 09006
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Palencia

    Palencia 3114531, Castille and León 3336900 34004
    Spain

    Active - Recruiting

  • Complejo Asistencial Universitario de Salamanca

    Salamanca 3111108, Castille and León 3336900 37007
    Spain

    Active - Recruiting

  • Hospital General de Segovia

    Segovia 3109256, Castille and León 3336900 40002
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid (HCUV)

    Valladolid 3106672, Castille and León 3336900 47003
    Spain

    Active - Recruiting

  • Complejo Hospitalario Zamora

    Zamora 3104342, Castille and León 3336900 49022
    Spain

    Active - Recruiting

  • Hospital Universitario Mancha Centro

    Alcázar de San Juan 2522131, Castille-La Mancha 2593111 13600
    Spain

    Active - Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real 2519402, Castille-La Mancha 2593111 13005
    Spain

    Active - Recruiting

  • Hospital Virgen de la Luz

    Cuenca 3124132, Castille-La Mancha 2593111 16002
    Spain

    Active - Recruiting

  • Hospital Universitario de Guadalajara

    Guadalajara 3121070, Castille-La Mancha 2593111 19002
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona 3128760, Catalonia 3336901 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona 3128760, Catalonia 3336901 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, Catalonia 3336901 08025
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona 3128760, Catalonia 3336901 08003
    Spain

    Active - Recruiting

  • Althaia Xarxa Assistencial Universitària de Manresa

    Manresa 3117533, Catalonia 3336901 08243
    Spain

    Site Not Available

  • Hospital Universitari Parc Taulí, Sabadell

    Sabadell 3111199, Catalonia 3336901 08208
    Spain

    Active - Recruiting

  • Hospital Universitari General de Catalunya

    Sant Cugat Del Vallés, Catalonia 3336901 08195
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Cataluña 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona, Cataluña 08035
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Cataluña 08025
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, Cataluña 08003
    Spain

    Active - Recruiting

  • Hospital Universitari Parc Taulí, Sabadell

    Sabadell, Cataluña 08208
    Spain

    Site Not Available

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallés, Cataluña 08195
    Spain

    Active - Recruiting

  • Hospital Universitario Príncipe de Asturias

    Alcalá de Henares, Comunidad Autónoma de Madrid 28805
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Leganés, Comunidad Autónoma de Madrid 28914
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, Comunidad Autónoma de Madrid 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Comunidad Autónoma de Madrid 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Comunidad Autónoma de Madrid 28222
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Comunidad Autónoma de Madrid 28223
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Vallecas, Comunidad Autónoma de Madrid 28031
    Spain

    Site Not Available

  • Hospital Universitario de Navarra

    Pamplona, Comunidad Foral de Navarra 31008
    Spain

    Site Not Available

  • Hospital Virgen de los Lirios

    Alcoi, Comunitat Valenciana 03804
    Spain

    Site Not Available

  • Hospital Universitario de la Ribera

    Alzira, Comunitat Valenciana 46600
    Spain

    Site Not Available

  • Hospital Universitario del Vinalopó

    Elx, Comunitat Valenciana 03293
    Spain

    Site Not Available

  • Hospital General de Requena

    Requena, Comunitat Valenciana 46340
    Spain

    Site Not Available

  • Hospital de Sagunto

    Sagunto, Comunitat Valenciana 46520
    Spain

    Site Not Available

  • Hospital Universitario de Torrevieja

    Torrevieja, Comunitat Valenciana 03186
    Spain

    Site Not Available

  • Consorcio Hospital General Universitario de València

    Valencia, Comunitat Valenciana 46014
    Spain

    Active - Recruiting

  • Hospital Arnau de Vilanova

    Valencia, Comunitat Valenciana 46015
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, Comunitat Valenciana 46017
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, Comunitat Valenciana 46026
    Spain

    Site Not Available

  • Instituto Valenciano de Oncología

    Valencia, Comunitat Valenciana 46009
    Spain

    Active - Recruiting

  • Hospital Marina Baixa

    Villajoyosa, Comunitat Valenciana 03570
    Spain

    Site Not Available

  • Hospital Lluis Alcanyís de Xàtiva

    Xativa, Comunitat Valenciana 46800
    Spain

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz, Extremadura 06080
    Spain

    Site Not Available

  • Hospital San Pedro de Alcántara

    Cáceres, Extremadura 10003
    Spain

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz 2521420, Extremadura 2593112 06080
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres 2520611, Extremadura 2593112 10003
    Spain

    Active - Recruiting

  • Centro Oncológico de Galicia

    A Coruña, Galicia 15009
    Spain

    Active - Recruiting

  • Hospital Universitario de A Coruña (CHUAC)

    A Coruña, Galicia 15006
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Ferrol

    Ferrol, Galicia 15405
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo, Galicia 27003
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario de Ourense

    Ourense, Galicia 32005
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Santiago ~ CHUS

    Santiago de Compostela, Galicia 15706
    Spain

    Site Not Available

  • Hospital Álvaro Cunqueiro

    Vigo, Galicia 36312
    Spain

    Site Not Available

  • Centro Oncológico de Galicia

    A Coruña 3119841, Galicia 3336902 15009
    Spain

    Active - Recruiting

  • Hospital Universitario de A Coruña (CHUAC)

    A Coruña 3119841, Galicia 3336902 15006
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Ferrol

    Ferrol 3123493, Galicia 3336902 15405
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo 3117814, Galicia 3336902 27003
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Ourense

    Ourense 3114965, Galicia 3336902 32005
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Santiago ~ CHUS

    Santiago de Compostela 3109642, Galicia 3336902 15706
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo 3105976, Galicia 3336902 36312
    Spain

    Active - Recruiting

  • Hospital Materno Infantil de Gran Canaria

    Las Palmas de Gran Canaria, Islas Canarias 35016
    Spain

    Site Not Available

  • Hospital Universitario San Pedro

    Logroño, La Rioja 26006
    Spain

    Site Not Available

  • Hospital Universitario San Pedro

    Logroño 3118150, La Rioja 3336897 26006
    Spain

    Active - Recruiting

  • Hospital Universitario Príncipe de Asturias

    Alcalá de Henares 3130616, Madrid 3117732 28805
    Spain

    Active - Recruiting

  • Hospital Universitario de Getafe

    Getafe 3121437, Madrid 3117732 28905
    Spain

    Active - Recruiting

  • Hospital Universitario Severo Ochoa

    Leganés 3118594, Madrid 3117732 28914
    Spain

    Active - Recruiting

  • Hospital Central de la Defensa Gómez Ulla

    Madrid 3117735, Madrid 3117732 28047
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid 3117735, Madrid 3117732 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, Madrid 3117732 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid 3117735, Madrid 3117732 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda 3117667, Madrid 3117732 28222
    Spain

    Active - Recruiting

  • Hospital Universitario de Móstoles

    Móstoles 3116025, Madrid 3117732 28935
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón 3112989, Madrid 3117732 28223
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Sofía

    San Sebastián, Madrid 3117732 28702
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Vallecas 3106601, Madrid 3117732 28031
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar 2518294, Murcia 2513413 30120
    Spain

    Active - Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia 2513416, Murcia 2513413 30008
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, País Vasco 48903
    Spain

    Site Not Available

  • Hospital Universitario Basurto

    Bilbao, País Vasco 48013
    Spain

    Site Not Available

  • Hospital Galdakao-Usansolo Ospitalea

    Galdakao, País Vasco 48960
    Spain

    Site Not Available

  • OSI Donostialdea - Onkologikoa

    San Sebastián, País Vasco 20014
    Spain

    Active - Recruiting

  • Hospital Universitario de Álava - Txagorritxu

    Vitoria, País Vasco 01009
    Spain

    Site Not Available

  • Hospital Universitario de Cabueñes

    Gijón 3121424, Principality of Asturias 3114710 33394
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo 3114711, Principality of Asturias 3114710 33011
    Spain

    Active - Recruiting

  • Hospital Virgen de los Lirios

    Alcoy 2522098, Valencia 2593113 03804
    Spain

    Active - Recruiting

  • Hospital Universitario de la Ribera

    Alzira 2522129, Valencia 2593113 46600
    Spain

    Active - Recruiting

  • Hospital Universitario del Vinalopó

    Elche 2518559, Valencia 2593113 03293
    Spain

    Active - Recruiting

  • Hospital General de Requena

    Requena 2511930, Valencia 2593113 46340
    Spain

    Active - Recruiting

  • Hospital de Sagunto

    Sagunto 2511619, Valencia 2593113 46520
    Spain

    Active - Recruiting

  • Hospital Universitario de Torrevieja

    Torrevieja 2510253, Valencia 2593113 03186
    Spain

    Active - Recruiting

  • Consorcio Hospital General Universitario de València

    Valencia 2509954, Valencia 2593113 46014
    Spain

    Active - Recruiting

  • Hospital Arnau de Vilanova

    Valencia 2509954, Valencia 2593113 46015
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia 2509954, Valencia 2593113 46010
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia 2509954, Valencia 2593113 46017
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia 2509954, Valencia 2593113 46026
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncología

    Valencia 2509954, Valencia 2593113 46009
    Spain

    Active - Recruiting

  • Hospital Marina Baixa

    Villajoyosa 2509588, Valencia 2593113 03570
    Spain

    Active - Recruiting

  • Hospital Lluis Alcanyís de Xàtiva

    Xàtiva 2516345, Valencia 2593113 46800
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008
    Spain

    Site Not Available

  • Hospital Universitario de Toledo

    Toledo,
    Spain

    Site Not Available

  • Hospital Universitario de Toledo

    Toledo 2510409,
    Spain

    Active - Recruiting

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