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

NCT ID: NCT06724159

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-13

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Genitourinary Cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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TRIDA Cohort

Patients with hormone-sensitive prostate carcinoma not castrated who have started treatment with darolutamide in combination with androgen deprivation therapy and docetaxel, from January 1, 2024

darolutamide

Intervention Type DRUG

Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice

NIADY Cohort

Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023

Nivolumab monotherapy

Intervention Type DRUG

Adjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice

EV3aL Cohort

Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024

enfortumab vedotin

Intervention Type DRUG

Following the posology and administration details of its marketing authorization and standard clinical practice

Interventions

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darolutamide

Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice

Intervention Type DRUG

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

Intervention Type DRUG

enfortumab vedotin

Following the posology and administration details of its marketing authorization and standard clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

* Evidence of an express objection by the subject or his/her legal representative to participate in the study.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MFAR

OTHER

Sponsor Role collaborator

Spanish Oncology Genito-Urinary Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Ángel Arranz Arija, M.D.; Ph.D.

Role: STUDY_CHAIR

Hospital General Universitario Gregorio Marañón de Madrid

Aránzazu González del Alba, M.D.; Ph.D.

Role: STUDY_CHAIR

Hospital Universitario Puerta de Hierro

Sergio Vázquez Estévez, M.D.; Ph.D.

Role: STUDY_CHAIR

Hospital Universitario Lucus Augusti

Locations

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Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, Spain

Site Status RECRUITING

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Torrecárdenas

Almería, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Clínico San Cecilio

Granada, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Virgen a de las Nieves

Granada, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario de Jaén

Jaén, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Jerez de la Frontera

Jerez de la Frontera, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, Andalusia, Spain

Site Status RECRUITING

Hospital Quirón Salud Sagrado Corazón de Sevilla

Seville, Andalusia, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario Virgen de Valme

Seville, Andalusia, Spain

Site Status RECRUITING

Hospital Universitario San Jorge

Huesca, Aragon, Spain

Site Status RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Site Status NOT_YET_RECRUITING

Hospital General Mateu Orfila

Maó, Balearic Islands, Spain

Site Status RECRUITING

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Site Status RECRUITING

Hospital Universitario Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Site Status RECRUITING

Hospital Universitario de Cruces

Barakaldo, Basque Country, Spain

Site Status RECRUITING

Hospital Universitario Basurto

Bilbao, Basque Country, Spain

Site Status RECRUITING

OSI Donostialdea - Onkologikoa

Donostia / San Sebastian, Basque Country, Spain

Site Status RECRUITING

Hospital Galdakao-Usansolo Ospitalea

Galdakao, Basque Country, Spain

Site Status RECRUITING

Hospital Universitario de Álava - Txagorritxu

Vitoria-Gasteiz, Basque Country, Spain

Site Status RECRUITING

Hospital Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Canary Islands, Spain

Site Status RECRUITING

Hospital Universitario de Burgos

Burgos, Castille and León, Spain

Site Status RECRUITING

Complejo Hospitalario de Palencia

Palencia, Castille and León, Spain

Site Status RECRUITING

Complejo Asistencial Universitario de Salamanca

Salamanca, Castille and León, Spain

Site Status RECRUITING

Hospital General de Segovia

Segovia, Castille and León, Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valladolid (HCUV)

Valladolid, Castille and León, Spain

Site Status RECRUITING

Complejo Hospitalario Zamora

Zamora, Castille and León, Spain

Site Status RECRUITING

Hospital Universitario Mancha Centro

Alcázar de San Juan, Castille-La Mancha, Spain

Site Status RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Castille-La Mancha, Spain

Site Status RECRUITING

Hospital Virgen de la Luz

Cuenca, Castille-La Mancha, Spain

Site Status RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, Castille-La Mancha, Spain

Site Status RECRUITING

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalonia, Spain

Site Status RECRUITING

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Catalonia, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Parc Taulí, Sabadell

Sabadell, Catalonia, Spain

Site Status RECRUITING

Hospital Universitari General de Catalunya

Sant Cugat Del Vallés, Catalonia, Spain

Site Status RECRUITING

Hospital Universitario de Badajoz

Badajoz, Extremadura, Spain

Site Status RECRUITING

Hospital San Pedro de Alcántara

Cáceres, Extremadura, Spain

Site Status RECRUITING

Hospital Universitario de A Coruña (CHUAC)

A Coruña, Galicia, Spain

Site Status RECRUITING

Centro Oncológico de Galicia

A Coruña, Galicia, Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Ferrol

Ferrol, Galicia, Spain

Site Status RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

Site Status RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, Galicia, Spain

Site Status RECRUITING

Hospital Clínico Universitario de Santiago ~ CHUS

Santiago de Compostela, Galicia, Spain

Site Status RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Galicia, Spain

Site Status RECRUITING

Hospital Universitario San Pedro

Logroño, La Rioja, Spain

Site Status RECRUITING

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Central de la Defensa Gómez Ulla

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status RECRUITING

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Infanta Sofía

San Sebastián, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Infanta Leonor

Vallecas, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Murcia, Spain

Site Status RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Virgen de los Lirios

Alcoy, Valencia, Spain

Site Status RECRUITING

Hospital Universitario de la Ribera

Alzira, Valencia, Spain

Site Status RECRUITING

Hospital Universitario del Vinalopó

Elche, Valencia, Spain

Site Status NOT_YET_RECRUITING

Hospital General de Requena

Requena, Valencia, Spain

Site Status RECRUITING

Hospital de Sagunto

Sagunto, Valencia, Spain

Site Status RECRUITING

Hospital Universitario de Torrevieja

Torrevieja, Valencia, Spain

Site Status RECRUITING

Instituto Valenciano de Oncología

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Site Status RECRUITING

Consorcio Hospital General Universitario de València

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Arnau de Vilanova

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Universitario Doctor Peset

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Marina Baixa

Villajoyosa, Valencia, Spain

Site Status RECRUITING

Hospital Lluis Alcanyís de Xàtiva

Xàtiva, Valencia, Spain

Site Status RECRUITING

Hospital Universitario de Toledo

Toledo, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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A Responsible Person Designated by the sponsor

Role: CONTACT

[email protected]
0034934344412

Facility Contacts

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Designated by the Sponsor

Role: primary

[email protected]
003496759710

Designated by the Sponsor

Role: primary

[email protected]

A responsible person Designated by the Sponsor

Role: primary

[email protected]
0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

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0034934344412

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0034934344412

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0034934344412

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0034 954 93 76 76

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0034934344412

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

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A responsible person Designated by the Sponsor

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A responsible person Designated by the Sponsor

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A responsible person Designated by the Sponsor

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A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

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0034 938 75 93 00

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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A responsible person Designated by the Sponsor

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A responsible person Designated by the Sponsor

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0034934344412

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003491 683 93 60

A responsible person Designated by the Sponsor

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0034 914 222 000

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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0034934344412

A responsible person Designated by the Sponsor

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[email protected]
0034934344412

Designated by the Sponsor

Role: primary

[email protected]
0034961973500

A responsible person Designated by the Sponsor

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[email protected]
0034934344412

A responsible person Designated by the Sponsor

Role: primary

[email protected]
0034934344412

A responsible person Designated by the Sponsor

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[email protected]
0034934344412

A responsible person Designated by the Sponsor

Role: primary

[email protected]
0034934344412

A responsible person Designated by the Sponsor

Role: primary

[email protected]
0034934344412

A responsible person Designated by the Sponsor

Role: primary

[email protected]
0034934344412

A responsible person Designated by the Sponsor

Role: primary

[email protected]
0034934344412

Other Identifiers

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SOGUG-PRINCIS

Identifier Type: -

Identifier Source: org_study_id

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