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

Condition(s) studied

Investigational drug(s) / intervention(s)

darolutamide: Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice

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

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

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.

Eligibility

Primary outcome measure(s)

• Progresion-free survival rate at 18 months — 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
• Relapse-free survival rate at 24 months — 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
• Overall survival rate at 12 months — 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

Trial sites (84)

+ 44 more sites — see the full list on the official registry below.

On this site

More Spanish Oncology Genito-Urinary Group trials in Spain