Clinical trial NCT06724159: Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genitourinary Cancers
Keywords: Urothelial carcinoma
Prostate adenocarcinoma
Renal carcinoma
Darolutamida
Nivolumab
Enfortumab Vedotin
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
Collaborators: name: MFAR
First posted: 2024-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with genitourinary cancers treated with new therapies following the standard clinical practice

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.


Eligibility criteria: 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.

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.
* 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.

Primary outcomes:
measure: Progresion-free survival rate at 18 months
timeFrame: 18 months after the initiation of study treatment
measure: Relapse-free survival rate at 24 months
timeFrame: 24 months after the first dose of study treatment
measure: Overall survival rate at 12 months
timeFrame: 12 months after the first dose of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
state: Andalucia
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Andalucia
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
state: Andalucia
city: Granada
country: Spain
facility: Hospital Universitario Virgen a de las Nieves
state: Andalucia
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
state: Andalucia
city: Jerez de la Frontera
country: Spain
facility: Hospital Universitario Jerez de la Frontera
state: Andalucia
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
state: Andalucia
city: Huesca
country: Spain
facility: Hospital Universitario San Jorge
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Mahón
country: Spain
facility: Hospital General Mateu Orfila
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Llàtzer
state: Baleares
city: Alcázar de San Juan
country: Spain
facility: Hospital Universitario Mancha Centro
state: Castilla la Mancha
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
state: Castilla la Mancha
city: Cuenca
country: Spain
facility: Hospital Virgen de la Luz
state: Castilla la Mancha
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
state: Castilla la Mancha
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla y Leon
city: Palencia
country: Spain
facility: Complejo Hospitalario de Palencia
state: Castilla y Leon
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
state: Castilla y Leon
city: Segovia
country: Spain
facility: Hospital General de Segovia
state: Castilla y Leon
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid (HCUV)
state: Castilla y Leon
city: Zamora
country: Spain
facility: Complejo Hospitalario Zamora
state: Castilla y Leon
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Cataluña
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí, Sabadell
state: Cataluña
city: Sant Cugat del Vallés
country: Spain
facility: Hospital Universitari General de Catalunya
state: Cataluña
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Comunidad Autónoma de Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Comunidad Autónoma de Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
state: Comunidad Autónoma de Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
state: Comunidad Autónoma de Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Comunidad Autónoma de Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Comunidad Autónoma de Madrid
city: Vallecas
country: Spain
facility: Hospital Universitario Infanta Leonor
state: Comunidad Autónoma de Madrid
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Comunidad Foral de Navarra
city: Alcoi
country: Spain
facility: Hospital Virgen de los Lirios
state: Comunitat Valenciana
city: Alzira
country: Spain
facility: Hospital Universitario de la Ribera
state: Comunitat Valenciana
city: Elx
country: Spain
facility: Hospital Universitario del Vinalopó
state: Comunitat Valenciana
city: Requena
country: Spain
facility: Hospital General de Requena
state: Comunitat Valenciana
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Comunitat Valenciana
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de València
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
state: Comunitat Valenciana
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Comunitat Valenciana
city: Xativa
country: Spain
facility: Hospital Lluis Alcanyís de Xàtiva
state: Comunitat Valenciana
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
state: Extremadura
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
state: Extremadura
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña (CHUAC)
state: Galicia
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
state: Galicia
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: Galicia
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
state: Galicia
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago ~ CHUS
state: Galicia
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Galicia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Materno Infantil de Gran Canaria
state: Islas Canarias
city: Logroño
country: Spain
facility: Hospital Universitario San Pedro
state: La Rioja
city: San Sebastián
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
state: País Vasco
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
state: País Vasco
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo Ospitalea
state: País Vasco
city: San Sebastián
country: Spain
facility: OSI Donostialdea - Onkologikoa
state: País Vasco
city: Vitoria
country: Spain
facility: Hospital Universitario de Álava - Txagorritxu
state: País Vasco
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón de Madrid
name: José Ángel Arranz Arija, M.D.; Ph.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Puerta de Hierro
name: Aránzazu González del Alba, M.D.; Ph.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Lucus Augusti
name: Sergio Vázquez Estévez, M.D.; Ph.D.
role: STUDY_CHAIR
References: