Taking people in SpainNo phase
Tracks how funded drugs work for genitourinary cancers in routine care
Collects data on darolutamide, nivolumab and enfortumab vedotin in adults with genitourinary cancers.
Key facts
- Who runs it
- Spanish Oncology Genito-Urinary Group
- Where
- A Coruña, Albacete, Alcalá de Henares, Alcázar de San Juan, Alcoy, Alicante, Almería, Alzira, Badajoz, Barakaldo, Barcelona, Bilbao, Burgos, Cáceres, Ciudad Real, Córdoba, Cuenca, Donostia / San Sebastian, El Palmar, Elche, Ferrol, Galdakao, Getafe, Gijón, Granada, Guadalajara, Huesca, Jaén, Jerez de la Frontera, Las Palmas de Gran Canaria, Leganés, Logroño, Lugo, Madrid, Mahón, Majadahonda, Málaga, Manresa, Móstoles, Murcia, Ourense, Oviedo, Palencia, Palma de Mallorca, Pamplona, Pozuelo de Alarcón, Requena, Sabadell, Sagunto, Salamanca, San Sebastián, Sant Cugat del Vallès, Santiago de Compostela, Segovia, Seville, Toledo, Torrevieja, Valencia, Valladolid, Vallecas, Vigo, Villajoyosa, Vitoria-Gasteiz, Xàtiva, Zamora, and Zaragoza, SpainSee the 84 sites
- Trial code
- Registry title
- Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 13 Dec 2024
- Expected to end
- Dec 2027
- Type of study
- Observational, 3 groups
- Treatments tested
- darolutamide
- Nivolumab monotherapy
- enfortumab vedotin
- Record updated
- 17 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study is looking for adults with a confirmed cancer of the genitourinary system who started a newly funded drug at a participating Spanish centre.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Cancer confirmed by tissue examination, starting in the kidney, renal pelvis, ureter, bladder, prostate, testicle or germinal tissue of other places, urethra, penis or seminal vesicles.
- Earlier treatment
- Started treatment with a drug that the Spanish National Health System agreed to fund after January 1, 2023. Treatment must have started after the official publication of that funding decision, at the participating centre.
Main reasons for not taking part
- Treated first at another centre, then sent to a participating centre
- Does not meet the inclusion criteria
- Patient or legal representative expressly objects to taking part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Spain
- Centro Oncologico de GaliciaA Coruña, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de A Coruña (CHUAC)A Coruña, SpainContact: A responsible person Designated by the SponsorTaking people
- Complejo Hospitalario Universitario de AlbaceteAlbacete, SpainContact: Designated by the SponsorTaking people
- Hospital Universitario Principe de AsturiasAlcalá de Henares, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Mancha CentroAlcázar de San Juan, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Virgen de Los LiriosAlcoy, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital General Universitario de AlicanteAlicante, SpainContact: Designated by the SponsorTaking people
- Hospital Universitario TorrecárdenasAlmería, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de La RiberaAlzira, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de BadajozBadajoz, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de CrucesBarakaldo, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital del MarBarcelona, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario BasurtoBilbao, SpainContact: Designated by the SponsorTaking people
- Hospital Universitario De BurgosBurgos, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital San Pedro De AlcántaraCáceres, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital General Universitario de Ciudad RealCiudad Real, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Virgen de la LuzCuenca, SpainContact: A responsible person Designated by the SponsorTaking people
- OSI Donostialdea - OnkologikoaDonostia / San Sebastian, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Virgen de la ArrixacaEl Palmar, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario del VinalopoElche, SpainContact: A responsible person Designated by the SponsorTaking people
- Complejo Hospitalario Universitario de FerrolFerrol, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Galdakao-Usansolo OspitaleaGaldakao, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de GetafeGetafe, SpainContact: Designated by the SponsorTaking people
- Hospital Universitario de CabueñesGijón, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Clínico San CecilioGranada, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Virgen a de las NievesGranada, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de GuadalajaraGuadalajara, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario San JorgeHuesca, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de JaénJaén, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Jerez De La FronteraJerez de la Frontera, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Materno Infantil de Gran CanariaLas Palmas de Gran Canaria, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Severo OchoaLeganés, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario San PedroLogroño, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Lucus AugustiLugo, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Central de la Defensa Gómez UllaMadrid, SpainContact: Designated by the SponsorTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainContact: Principal investigator Designated by the Sponsor, M.D.; Ph.D. (principal investigator)Taking people
- Hospital General Mateu OrfilaMahón, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Puerta de HierroMajadahonda, SpainContact: Designated by the SponsorTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainContact: A responsible person Designated by the SponsorTaking people
- ALTHAIA, Xarxa Assistencial Universitaria de Manresa.Manresa, SpainContact: Designated by the SponsorNot yet recruiting
- Hospital Universitario De MóstolesMóstoles, SpainContact: Designated by the SponsorTaking people
- Hospital General Universitario Morales MeseguerMurcia, SpainContact: A responsible person Designated by the SponsorTaking people
- Complexo Hospitalario Universitario de OurenseOurense, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainContact: A responsible person Designated by the SponsorTaking people
- Complejo Hospitalario de PalenciaPalencia, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Son EspasesPalma de Mallorca, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Son LlatzerPalma de Mallorca, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de NavarraPamplona, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital General de RequenaRequena, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitari Parc Taulí, SabadellSabadell, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital de SaguntoSagunto, SpainContact: A responsible person Designated by the SponsorTaking people
- Complejo Asistencial Universitario de SalamancaSalamanca, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Infanta SofíaSan Sebastián, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitari General de CatalunyaSant Cugat del Vallès, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Clínico Universitario de Santiago CHUSSantiago de Compostela, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital General de SegoviaSegovia, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Quirón Salud Sagrado Corazón de SevillaSeville, SpainContact: Designated by the SponsorNot yet recruiting
- Hospital Universitario Virgen de ValmeSeville, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Virgen del RocioSeville, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Virgen MacarenaSeville, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de ToledoToledo, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de TorreviejaTorrevieja, SpainContact: A responsible person Designated by the SponsorTaking people
- Consorcio Hospital General Universitario de ValenciaValencia, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Arnau de VilanovaValencia, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainContact: Designated by the SponsorTaking people
- Hospital Universitario Doctor PesetValencia, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainContact: A responsible person Designated by the SponsorTaking people
- Instituto Valenciano de OncologiaValencia, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Clínico Universitario de Valladolid (HCUV)Valladolid, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Infanta LeonorVallecas, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Alvaro CunqueiroVigo, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Marina BaixaVillajoyosa, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario de Álava - TxagorritxuVitoria-Gasteiz, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Lluis Alcanyís de XàtivaXàtiva, SpainContact: A responsible person Designated by the SponsorTaking people
- Complejo Hospitalario ZamoraZamora, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpainContact: A responsible person Designated by the SponsorTaking people
- Hospital Universitario Miguel ServetZaragoza, SpainContact: A responsible person Designated by the SponsorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- 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
Treatment: darolutamide
- NIADY Cohort
Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023
Treatment: Nivolumab monotherapy
- EV3aL Cohort
Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024
Treatment: enfortumab vedotin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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.
- Plain-language title
- Tracks how funded drugs work for genitourinary cancers in routine careGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 February 2026