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

Recruiting

• Conditions: Genitourinary Cancers
• Interventions: Drug: darolutamide; Drug: Nivolumab monotherapy; Drug: enfortumab vedotin

• Registration Number: NCT06724159
• Lead Sponsor: Spanish Oncology Genito-Urinary Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Study Start: 2024-12-13
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-04
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TRIDA Cohort	darolutamide	Patients with hormone-sensitive prostate carcinoma not castrated who have started treatment with darolutamide in combination with androgen deprivation therapy and docetaxel, from January 1, 2024
NIADY Cohort	Nivolumab monotherapy	Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023
EV3aL Cohort	enfortumab vedotin	Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (76)

Hospital Universitario Torrecárdenas; 🇪🇸 Almería, Andalucia, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Andalucia, Spain

Hospital Universitario Clínico San Cecilio; 🇪🇸 Granada, Andalucia, Spain

Hospital Universitario Virgen a de las Nieves; 🇪🇸 Granada, Andalucia, Spain

Hospital Universitario de Jaén; 🇪🇸 Jaén, Andalucia, Spain

Hospital Universitario Jerez de la Frontera; 🇪🇸 Jerez de la Frontera, Andalucia, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Andalucia, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Andalucia, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Andalucia, Spain

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Andalucia, Spain

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