Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: darolutamide, Nivolumab monotherapy, enfortumab vedotin.
- Who it may be relevant to
- Registry conditions: Genitourinary Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PRINCIS Study ("Public Health Clinical Research Project"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.
Overview
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.
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
Primary outcome measures
- Progresion-free survival rate at 18 months [Time frame: 18 months after the initiation of study treatment]
- Relapse-free survival rate at 24 months [Time frame: 24 months after the first dose of study treatment]
- Overall survival rate at 12 months [Time frame: 12 months after the first dose of study treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 84 centers
- Complejo Hospitalario Universitario de Albacete — Albacete
- Hospital General Universitario de Alicante — Alicante
- Hospital Universitario Torrecárdenas — Almería
- Hospital Universitario Reina Sofía — Córdoba
- Hospital Universitario Clínico San Cecilio — Granada
- Hospital Universitario Virgen a de las Nieves — Granada
- Hospital Universitario de Jaén — Jaén
- Hospital Universitario Jerez de la Frontera — Jerez de la Frontera
- … and 76 more centers
Identifiers
NCT: NCT06724159 · SOGUG-PRINCIS