MedTrace Logo

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

NCT06724159 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-02-17

No results posted yet for this study

Summary

SOGUG-PRINCIS is a retrospective (regarding patient inclusion) and prospective follow-up, epidemiological, non-interventional, non-blinded, non-randomized, multicenter, national observational study with drugs. This study will collect data from patients with genitourinary tumors to analyze the effectiveness under routine clinical practice conditions of drugs recently approved for funding in the Spanish National Health System.

In all cases, the decision to start treatment will be made prior to and independently of participation in the study, which will be limited to subsequently collecting the data necessary to assess the objectives of the study.

This study will serve as a registry for genitourinary cancers. Every time a new drug will be authorized, a new subproject with a primary endpoint will be opened to recruitment. The substudy will try to validate with real-world data the endpoints reported in the phase III clinical trials that led to the marketin authorization.

Conditions

Interventions

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

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

DRUG

enfortumab vedotin

Following the posology and administration details of its marketing authorization and standard clinical practice

Sponsors & Collaborators

  • MFAR

    collaborator OTHER

  • Spanish Oncology Genito-Urinary Group

    lead OTHER

Principal Investigators

  • José Ángel Arranz Arija, M.D.; Ph.D. · Hospital General Universitario Gregorio Marañón de Madrid

  • Aránzazu González del Alba, M.D.; Ph.D. · Hospital Universitario Puerta de Hierro

  • Sergio Vázquez Estévez, M.D.; Ph.D. · Hospital Universitario Lucus Augusti

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724159 on ClinicalTrials.gov