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Real-World check: do new cancer drugs deliver outside trials?

NCT ID NCT06724159

Knowledge-focused Sponsor: Spanish Oncology Genito-Urinary Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 500 people with genitourinary cancers (like prostate, bladder, or kidney cancer) to see how well recently approved drugs work in everyday Spanish hospitals. Researchers will collect data from patients already taking these medications, without changing their treatment. The goal is to confirm that results from earlier clinical trials hold up in real-world conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
darolutamide, nivolumab, enfortumab vedotin
What this could lead to
If successful, this study could confirm that new cancer drugs work as well in everyday clinics as they did in earlier trials, helping doctors choose the best treatments.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only looks at drugs already approved, so it won't test new experimental treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

malignant urinary system neoplasm renal cell carcinoma transitional cell carcinoma Urogenital Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genitourinary cancers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    84 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Althaia Xarxa Assistencial Universitària de Manresa

    NOT_YET_RECRUITING

    Manresa, Catalonia, 08243, Spain

  • Centro Oncológico de Galicia

    RECRUITING

    A Coruña, Galicia, 15009, Spain

  • Complejo Asistencial Universitario de Salamanca

    RECRUITING

    Salamanca, Castille and León, 37007, Spain

  • Complejo Hospitalario Universitario de Albacete

    RECRUITING

    Albacete, Albacete, 02006, Spain

  • Complejo Hospitalario Universitario de Ferrol

    RECRUITING

    Ferrol, Galicia, 15405, Spain

  • Complejo Hospitalario Zamora

    RECRUITING

    Zamora, Castille and León, 49022, Spain

  • Complejo Hospitalario de Palencia

    RECRUITING

    Palencia, Castille and León, 34004, Spain

  • Complexo Hospitalario Universitario de Ourense

    RECRUITING

    Ourense, Galicia, 32005, Spain

  • Consorcio Hospital General Universitario de València

    RECRUITING

    Valencia, Valencia, 46014, Spain

  • Hospital Arnau de Vilanova

    RECRUITING

    Valencia, Valencia, 46015, Spain

  • Hospital Central de la Defensa Gómez Ulla

    RECRUITING

    Madrid, Madrid, 28047, Spain

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, Aragon, 50009, Spain

  • Hospital Clínico Universitario de Santiago ~ CHUS

    RECRUITING

    Santiago de Compostela, Galicia, 15706, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Hospital Clínico Universitario de Valladolid (HCUV)

    RECRUITING

    Valladolid, Castille and León, 47003, Spain

  • Hospital Galdakao-Usansolo Ospitalea

    RECRUITING

    Galdakao, Basque Country, 48960, Spain

  • Hospital General Mateu Orfila

    RECRUITING

    Mahón, Balearic Islands, 07703, Spain

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, Murcia, 30008, Spain

  • Hospital General Universitario de Alicante

    RECRUITING

    Alicante, Alicante, 03010, Spain

  • Hospital General Universitario de Ciudad Real

    RECRUITING

    Ciudad Real, Castille-La Mancha, 13005, Spain

  • Hospital General de Requena

    RECRUITING

    Requena, Valencia, 46340, Spain

  • Hospital General de Segovia

    RECRUITING

    Segovia, Castille and León, 40002, Spain

  • Hospital Lluis Alcanyís de Xàtiva

    RECRUITING

    Xàtiva, Valencia, 46800, Spain

  • Hospital Marina Baixa

    RECRUITING

    Villajoyosa, Valencia, 03570, Spain

  • Hospital Materno Infantil de Gran Canaria

    RECRUITING

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

  • Hospital Quirón Salud Sagrado Corazón de Sevilla

    NOT_YET_RECRUITING

    Seville, Andalusia, 41013, Spain

  • Hospital San Pedro de Alcántara

    RECRUITING

    Cáceres, Extremadura, 10003, Spain

  • Hospital Son Espases

    RECRUITING

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Hospital Universitari General de Catalunya

    RECRUITING

    Sant Cugat Del Vallés, Catalonia, 08195, Spain

  • Hospital Universitari Parc Taulí, Sabadell

    RECRUITING

    Sabadell, Catalonia, 08208, Spain

  • Hospital Universitari Vall d'Hebrón

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario Basurto

    RECRUITING

    Bilbao, Basque Country, 48013, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, Andalusia, 18007, Spain

  • Hospital Universitario Doctor Peset

    RECRUITING

    Valencia, Valencia, 46017, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Vallecas, Madrid, 28031, Spain

  • Hospital Universitario Infanta Sofía

    RECRUITING

    San Sebastián, Madrid, 28702, Spain

  • Hospital Universitario Jerez de la Frontera

    RECRUITING

    Jerez de la Frontera, Andalusia, 11407, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, Galicia, 27003, Spain

  • Hospital Universitario Mancha Centro

    RECRUITING

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

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, Aragon, 50009, Spain

  • Hospital Universitario Príncipe de Asturias

    RECRUITING

    Alcalá de Henares, Madrid, 28805, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Quironsalud Madrid

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía

    RECRUITING

    Córdoba, Andalusia, 14004, Spain

  • Hospital Universitario San Jorge

    RECRUITING

    Huesca, Aragon, 22004, Spain

  • Hospital Universitario San Pedro

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • Hospital Universitario Severo Ochoa

    RECRUITING

    Leganés, Madrid, 28914, Spain

  • Hospital Universitario Son Llàtzer

    RECRUITING

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Universitario Torrecárdenas

    RECRUITING

    Almería, Andalusia, 04009, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • Hospital Universitario Virgen a de las Nieves

    RECRUITING

    Granada, Andalusia, 18014, Spain

  • Hospital Universitario Virgen de Valme

    RECRUITING

    Seville, Andalusia, 41014, Spain

  • Hospital Universitario Virgen de la Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • Hospital Universitario de A Coruña (CHUAC)

    RECRUITING

    A Coruña, Galicia, 15006, Spain

  • Hospital Universitario de Badajoz

    RECRUITING

    Badajoz, Extremadura, 06080, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, Castille and León, 09006, Spain

  • Hospital Universitario de Cabueñes

    RECRUITING

    Gijón, Principality of Asturias, 33394, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, Basque Country, 48903, Spain

  • Hospital Universitario de Getafe

    RECRUITING

    Getafe, Madrid, 28905, Spain

  • Hospital Universitario de Guadalajara

    RECRUITING

    Guadalajara, Castille-La Mancha, 19002, Spain

  • Hospital Universitario de Jaén

    RECRUITING

    Jaén, Andalusia, 23007, Spain

  • Hospital Universitario de Móstoles

    RECRUITING

    Móstoles, Madrid, 28935, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Hospital Universitario de Toledo

    RECRUITING

    Toledo, Spain

  • Hospital Universitario de Torrevieja

    RECRUITING

    Torrevieja, Valencia, 03186, Spain

  • Hospital Universitario de la Ribera

    RECRUITING

    Alzira, Valencia, 46600, Spain

  • Hospital Universitario de Álava - Txagorritxu

    RECRUITING

    Vitoria-Gasteiz, Basque Country, 01009, Spain

  • Hospital Universitario del Vinalopó

    RECRUITING

    Elche, Valencia, 03293, Spain

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Virgen de la Luz

    RECRUITING

    Cuenca, Castille-La Mancha, 16002, Spain

  • Hospital Virgen de los Lirios

    RECRUITING

    Alcoy, Valencia, 03804, Spain

  • Hospital de Sagunto

    RECRUITING

    Sagunto, Valencia, 46520, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalonia, 08025, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

  • Hospital Álvaro Cunqueiro

    RECRUITING

    Vigo, Galicia, 36312, Spain

  • Instituto Valenciano de Oncología

    RECRUITING

    Valencia, Valencia, 46009, Spain

  • OSI Donostialdea - Onkologikoa

    RECRUITING

    Donostia / San Sebastian, Basque Country, 20014, Spain

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Other studies related to the condition(s) this trial covers.