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

NCT06724159 | Recruiting

• 1 other identifier: SOGUG-PRINCIS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 84

Brief 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.

Conditions

Genitourinary Cancers

Keywords

Urothelial carcinoma; Prostate adenocarcinoma; Renal carcinoma; Darolutamida; Nivolumab; Enfortumab Vedotin

Outcome Measures

Primary Outcomes (3)

• Progresion-free survival rate at 18 months

  For TRIDA substudy. Defined as the percentage of patients alive and free of progression of the disease (estimated by Kaplan-Meier method) at 18 months. Patients without event are censored in their last follow-up

  18 months after the initiation of study treatment

• Relapse-free survival rate at 24 months

  For NIADY substudy. Defined as the percentage of patients alive and with no disease recurrence (estimated by Kaplan-Meier method) at 24 months

  24 months after the first dose of study treatment

• Overall survival rate at 12 months

  For EV3aL substudy Defined as the percentage of patients alive (estimated by Kaplan-Meier method) at 12 months

  12 months after the first dose of study treatment

Study Arms (3)

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

Drug: darolutamide

NIADY Cohort

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

Drug: Nivolumab monotherapy

EV3aL Cohort

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

Drug: enfortumab vedotin

Interventions

Nivolumab monotherapy DRUG

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

NIADY Cohort

enfortumab vedotin DRUG

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

EV3aL Cohort

darolutamide DRUG

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

TRIDA Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with genitourinary cancers treated with new therapies following the standard clinical practice

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• MFAR: collaborator

Study Sites (84)

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, 02006, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

Hospital Universitario Torrecárdenas

Almería, Andalusia, 04009, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Andalusia, 14004, Spain

RECRUITING

Hospital Universitario Clínico San Cecilio

Granada, Andalusia, 18007, Spain

RECRUITING

Hospital Universitario Virgen a de las Nieves

Granada, Andalusia, 18014, Spain

RECRUITING

Hospital Universitario de Jaén

Jaén, Andalusia, 23007, Spain

RECRUITING

Hospital Universitario Jerez de la Frontera

Jerez de la Frontera, Andalusia, 11407, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

RECRUITING

Hospital Quirón Salud Sagrado Corazón de Sevilla

Seville, Andalusia, 41013, Spain

NOT YET RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

RECRUITING

Hospital Universitario Virgen de Valme

Seville, Andalusia, 41014, Spain

RECRUITING

Hospital Universitario San Jorge

Huesca, Aragon, 22004, Spain

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

RECRUITING

Hospital General Mateu Orfila

Mahón, Balearic Islands, 07703, Spain

RECRUITING

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

Hospital Universitario Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

RECRUITING

Hospital Universitario de Cruces

Barakaldo, Basque Country, 48903, Spain

RECRUITING

Hospital Universitario Basurto

Bilbao, Basque Country, 48013, Spain

RECRUITING

OSI Donostialdea - Onkologikoa

Donostia / San Sebastian, Basque Country, 20014, Spain

RECRUITING

Hospital Galdakao-Usansolo Ospitalea

Galdakao, Basque Country, 48960, Spain

RECRUITING

Hospital Universitario de Álava - Txagorritxu

Vitoria-Gasteiz, Basque Country, 01009, Spain

RECRUITING

Hospital Materno Infantil de Gran Canaria

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

RECRUITING

Hospital Universitario de Burgos

Burgos, Castille and León, 09006, Spain

RECRUITING

Complejo Hospitalario de Palencia

Palencia, Castille and León, 34004, Spain

RECRUITING

Complejo Asistencial Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

RECRUITING

Hospital General de Segovia

Segovia, Castille and León, 40002, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid (HCUV)

Valladolid, Castille and León, 47003, Spain

RECRUITING

Complejo Hospitalario Zamora

Zamora, Castille and León, 49022, Spain

RECRUITING

Hospital Universitario Mancha Centro

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

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Castille-La Mancha, 13005, Spain

RECRUITING

Hospital Virgen de la Luz

Cuenca, Castille-La Mancha, 16002, Spain

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, Castille-La Mancha, 19002, Spain

RECRUITING

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Catalonia, 08243, Spain

NOT YET RECRUITING

Hospital Universitari Parc Taulí, Sabadell

Sabadell, Catalonia, 08208, Spain

RECRUITING

Hospital Universitari General de Catalunya

Sant Cugat Del Vallés, Catalonia, 08195, Spain

RECRUITING

Hospital Universitario de Badajoz

Badajoz, Extremadura, 06080, Spain

RECRUITING

Hospital San Pedro de Alcántara

Cáceres, Extremadura, 10003, Spain

RECRUITING

Hospital Universitario de A Coruña (CHUAC)

A Coruña, Galicia, 15006, Spain

RECRUITING

Centro Oncológico de Galicia

A Coruña, Galicia, 15009, Spain

RECRUITING

Complejo Hospitalario Universitario de Ferrol

Ferrol, Galicia, 15405, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Galicia, 27003, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, Galicia, 32005, Spain

RECRUITING

Hospital Clínico Universitario de Santiago ~ CHUS

Santiago de Compostela, Galicia, 15706, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Galicia, 36312, Spain

RECRUITING

Hospital Universitario San Pedro

Logroño, La Rioja, 26006, Spain

RECRUITING

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28914, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Central de la Defensa Gómez Ulla

Madrid, Madrid, 28047, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario de Móstoles

Móstoles, Madrid, 28935, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Universitario Infanta Sofía

San Sebastián, Madrid, 28702, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Vallecas, Madrid, 28031, Spain

RECRUITING

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Murcia, 30008, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, 33394, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Virgen de los Lirios

Alcoy, Valencia, 03804, Spain

RECRUITING

Hospital Universitario de la Ribera

Alzira, Valencia, 46600, Spain

RECRUITING

Hospital Universitario del Vinalopó

Elche, Valencia, 03293, Spain

RECRUITING

Hospital General de Requena

Requena, Valencia, 46340, Spain

RECRUITING

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

RECRUITING

Hospital Universitario de Torrevieja

Torrevieja, Valencia, 03186, Spain

RECRUITING

Instituto Valenciano de Oncología

Valencia, Valencia, 46009, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Consorcio Hospital General Universitario de València

Valencia, Valencia, 46014, Spain

RECRUITING

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, Valencia, 46017, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Marina Baixa

Villajoyosa, Valencia, 03570, Spain

RECRUITING

Hospital Lluis Alcanyís de Xàtiva

Xàtiva, Valencia, 46800, Spain

RECRUITING

Hospital Universitario de Toledo

Toledo, Spain

RECRUITING

MeSH Terms

Conditions

Urogenital Neoplasms; Carcinoma, Transitional Cell; Carcinoma, Renal Cell

Interventions

darolutamide; enfortumab vedotin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases

Study Officials

• José Ángel Arranz Arija, M.D.; Ph.D.

  Hospital General Universitario Gregorio Marañón de Madrid

  STUDY CHAIR

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

  Hospital Universitario Puerta de Hierro

  STUDY CHAIR

• Sergio Vázquez Estévez, M.D.; Ph.D.

  Hospital Universitario Lucus Augusti

  STUDY CHAIR

Central Study Contacts

A Responsible Person Designated by the sponsor

CONTACT

0034934344412; investigacio@mfar.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

ES (84)