Observational Study on the Effectiveness of New Drugs Funded by the Spanish National Health System for Genitourinary Cancers

What this Trial Is About

Researchers are conducting a national, multicenter observational study called SOGUG-PRINCIS to collect and analyze data on patients with genitourinary cancers treated with recently approved drugs under routine clinical practice in Spain. This study is both retrospective and prospective, aiming to validate real-world effectiveness of these drugs and support future funding decisions. It will serve as a registry where new subprojects will open whenever new drugs receive authorization. The study follows patients who have started treatment with specific drugs funded by the Spanish National Health System, including darolutamide combined with androgen deprivation therapy and docetaxel for hormone-sensitive prostate cancer, adjuvant nivolumab after surgery for urothelial carcinoma, and enfortumab vedotin for urothelial carcinoma. All treatments follow their approved dosing and administration guidelines and standard clinical practice. Participants progress will be monitored through routine data collection to evaluate outcomes such as progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after starting treatment. Data will be gathered from patients treated at participating centers, with follow-up continuing as per routine care. The study does not intervene in treatment decisions, which are made independently before enrollment.

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