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 Type
OBSERVATIONAL
Enrollment
500
Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice
Adjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice
Following the posology and administration details of its marketing authorization and standard clinical practice
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, Spain
RECRUITINGHospital General Universitario de Alicante
Alicante, Alicante, Spain
RECRUITINGHospital Universitario Torrecárdenas
Almería, Andalusia, Spain
RECRUITINGHospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
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
Time frame: 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
Time frame: 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
Time frame: 12 months after the first dose of study treatment
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Hospital Universitario Clínico San Cecilio
Granada, Andalusia, Spain
RECRUITINGHospital Universitario Virgen a de las Nieves
Granada, Andalusia, Spain
RECRUITINGHospital Universitario de Jaén
Jaén, Andalusia, Spain
RECRUITINGHospital Universitario Jerez de la Frontera
Jerez de la Frontera, Andalusia, Spain
RECRUITINGHospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
RECRUITINGHospital Universitario Virgen Macarena
Seville, Andalusia, Spain
RECRUITING...and 74 more locations