Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors. (SOGUG-PRINCIS)

February 13, 2026 updated by: Spanish Oncology Genito-Urinary Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: A Responsible Person Designated by the sponsor
  • Phone Number: 0034934344412
  • Email: investigacio@mfar.net

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
EV3aL Cohort
Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024
Drug: enfortumab vedotin
Following the posology and administration details of its marketing authorization and standard clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months after the initiation of study treatment
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
24 months after the first dose of study treatment
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
12 months after the first dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

MFAR

Investigators

  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOGUG-PRINCIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No IDP sharing is prestablished

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Genitourinary Cancers

Clinical Trials on darolutamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe