Genitourinary CancersSOGUG-PRINCISNCT06724159

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

An observational study of Genitourinary Cancers, run by Spanish Oncology Genito-Urinary Group at 84 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Genitourinary Cancers
What is being tested?: darolutamide, Nivolumab monotherapy and enfortumab vedotin
How many people: 500 participants
Where: 84 sitesSpain
Study dates: 13 Dec 2024to Dec 2027
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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 join

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.

Trial locations and contacts

84 sites in 1 country. Contact the study team or a site near you to ask about taking part.

A Responsible Person Designated by the sponsor contact

0034934344412

investigacio@mfar.net

City, postcode or hospital

Sites recruiting now only

84 sites in 1 country

Spain84 sites, 84 recruiting

Hospital Universitario de A Coruña (CHUAC)
A Coruña, Galicia, 15006
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Centro Oncológico de Galicia
A Coruña, Galicia, 15009
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, 02006
Designated by the Sponsor, 003496759710, investigacion@mfar.net
Recruiting
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Mancha Centro
Alcázar de San Juan, Castille-La Mancha, 13600
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Virgen de los Lirios
Alcoy, Valencia, 03804
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
Designated by the Sponsor, investigacion@mfar.net
Recruiting
Hospital Universitario Torrecárdenas
Almería, Andalusia, 04009
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de la Ribera
Alzira, Valencia, 46600
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Badajoz
Badajoz, Extremadura, 06080
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor
Recruiting
Hospital Universitario de Cruces
Barakaldo, Basque Country, 48903
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital del Mar
Barcelona, Catalonia, 08003
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, Catalonia, 08035
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Basurto
Bilbao, Basque Country, 48013
Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Burgos
Burgos, Castille and León, 09006
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital San Pedro de Alcántara
Cáceres, Extremadura, 10003
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, Castille-La Mancha, 13005
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Reina Sofía
Córdoba, Andalusia, 14004
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Virgen de la Luz
Cuenca, Castille-La Mancha, 16002
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
OSI Donostialdea - Onkologikoa
Donostia / San Sebastian, Basque Country, 20014
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario del Vinalopó
Elche, Valencia, 03293
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Complejo Hospitalario Universitario de Ferrol
Ferrol, Galicia, 15405
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Galdakao-Usansolo Ospitalea
Galdakao, Basque Country, 48960
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Designated by the Sponsor, 003491 683 93 60, investigacion@mfar.net
Recruiting
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, 33394
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Clínico San Cecilio
Granada, Andalusia, 18007
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Virgen a de las Nieves
Granada, Andalusia, 18014
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Guadalajara
Guadalajara, Castille-La Mancha, 19002
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario San Jorge
Huesca, Aragon, 22004
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Jaén
Jaén, Andalusia, 23007
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Andalusia, 11407
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35016
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28914
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario San Pedro
Logroño, La Rioja, 26006
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
0034934344412, investigacion@mfar.net
Principal investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor
Recruiting
Hospital Central de la Defensa Gómez Ulla
Madrid, Madrid, 28047
Designated by the Sponsor, 0034 914 222 000, investigacion@mfar.net
Recruiting
Hospital General Mateu Orfila
Mahón, Balearic Islands, 07703
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Catalonia, 08243
Designated by the Sponsor, 0034 938 75 93 00, investigacion@mfar.net
Not yet recruiting
Hospital Universitario de Móstoles
Móstoles, Madrid, 28935
Designated by the Sponsor, 0034 91 664 86 00, investigacion@mfar.net
Recruiting
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, 32005
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Complejo Hospitalario de Palencia
Palencia, Castille and León, 34004
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital General de Requena
Requena, Valencia, 46340
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitari Parc Taulí, Sabadell
Sabadell, Catalonia, 08208
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital de Sagunto
Sagunto, Valencia, 46520
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca, Castille and León, 37007
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Infanta Sofía
San Sebastián, Madrid, 28702
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitari General de Catalunya
Sant Cugat Del Vallés, Catalonia, 08195
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Clínico Universitario de Santiago ~ CHUS
Santiago de Compostela, Galicia, 15706
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital General de Segovia
Segovia, Castille and León, 40002
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Quirón Salud Sagrado Corazón de Sevilla
Seville, Andalusia, 41013
Designated by the Sponsor, 0034 954 93 76 76, investigacion@mfar.net
Not yet recruiting
Hospital Universitario Virgen del Rocío
Seville, Andalusia, 41013
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Virgen de Valme
Seville, Andalusia, 41014
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Toledo
Toledo
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Torrevieja
Torrevieja, Valencia, 03186
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Instituto Valenciano de Oncología
Valencia, Valencia, 46009
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor
Recruiting
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
Designated by the Sponsor, 0034961973500, investigacion@mfar.net
Recruiting
Consorcio Hospital General Universitario de València
Valencia, Valencia, 46014
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Doctor Peset
Valencia, Valencia, 46017
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Clínico Universitario de Valladolid (HCUV)
Valladolid, Castille and León, 47003
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Infanta Leonor
Vallecas, Madrid, 28031
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Álvaro Cunqueiro
Vigo, Galicia, 36312
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Marina Baixa
Villajoyosa, Valencia, 03570
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario de Álava - Txagorritxu
Vitoria-Gasteiz, Basque Country, 01009
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Lluis Alcanyís de Xàtiva
Xàtiva, Valencia, 46800
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Complejo Hospitalario Zamora
Zamora, Castille and León, 49022
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009
A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net
A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.
Recruiting

Other trials in Spain

About this study

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.

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
Being tested: darolutamide, Nivolumab monotherapy, enfortumab vedotin
Keywords: Urothelial carcinoma, Prostate adenocarcinoma, Renal carcinoma, Darolutamida, Nivolumab, Enfortumab Vedotin
Medical subject headings: Urogenital Neoplasms, Carcinoma, Transitional Cell, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

darolutamideDrug
Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice
Nivolumab monotherapyDrug
Adjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice
enfortumab vedotinDrug
Following the posology and administration details of its marketing authorization and standard clinical practice

Study groups in NCT06724159
Study group	Role	What they receive
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 Receives: Drug: darolutamide
NIADY Cohort		Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023 Receives: Drug: Nivolumab monotherapy
EV3aL Cohort		Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024 Receives: Drug: enfortumab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 12 months after the first dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 2024Dec 2027

First posted9 Dec 2024
Study start13 Dec 2024
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Genitourinary CancersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 500 participants (estimated)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06724159
Sponsor's protocol ID: SOGUG-PRINCIS
Acronym: SOGUG-PRINCIS
Status last verified: Feb 2026
First submitted: 4 Dec 2024
Last updated: 17 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: No IDP sharing is prestablished

Interested in taking part?

A Responsible Person Designated by the sponsor

0034934344412

investigacio@mfar.net

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT06724159
Acronym / sponsor ID: SOGUG-PRINCIS / SOGUG-PRINCIS
Conditions: Genitourinary Cancers
Keywords: Urothelial carcinoma, Prostate adenocarcinoma, Renal carcinoma, Darolutamida, Nivolumab, Enfortumab Vedotin
Study type: Observational
Recruitment status: Recruiting
Enrolment: 500 participants (estimated)
Lead sponsor: Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
Collaborators: MFAR
Study start: 13 Dec 2024 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 9 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 3 Years
Number of arms: 3

Arm	Type	Receives
TRIDA Cohort	–	Drug: darolutamidePatients 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
NIADY Cohort	–	Drug: Nivolumab monotherapyPatients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023
EV3aL Cohort	–	Drug: enfortumab vedotinPatients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with genitourinary cancers treated with new therapies following the standard clinical practice

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
darolutamideDarolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice	Drug	TRIDA Cohort
Nivolumab monotherapyAdjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice	Drug	NIADY Cohort
enfortumab vedotinFollowing the posology and administration details of its marketing authorization and standard clinical practice	Drug	EV3aL Cohort

Primary outcome

Progresion-free survival rate at 18 months
Time frame: 18 months after the initiation of study treatment
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
Relapse-free survival rate at 24 months
Time frame: 24 months after the first dose of study treatment
For NIADY substudy. Defined as the percentage of patients alive and with no disease recurrence (estimated by Kaplan-Meier method) at 24 months
Overall survival rate at 12 months
Time frame: 12 months after the first dose of study treatment
For EV3aL substudy Defined as the percentage of patients alive (estimated by Kaplan-Meier method) at 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Individual participant dataSharing planned: Undecided. No IDP sharing is prestablished

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

A Responsible Person Designated by the sponsor contact

0034934344412

investigacio@mfar.net

José Ángel Arranz Arija, M.D.; Ph.D. study chair

Hospital General Universitario Gregorio Marañón de Madrid

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

Hospital Universitario Puerta de Hierro

Sergio Vázquez Estévez, M.D.; Ph.D. study chair

Hospital Universitario Lucus Augusti

84 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Genitourinary Cancers, run by Spanish Oncology Genito-Urinary Group at 84 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact A Responsible Person Designated by the sponsor (0034934344412, investigacio@mfar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progresion-free survival rate at 18 months (time frame: 18 months after the initiation of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06724159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.