PRINCIS Study ("Public Health Clinical Research Project"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 84
- Primary Endpoint
- Progresion-free survival rate at 18 months
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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.
Arms & Interventions
EV3aL Cohort
Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024
Intervention: enfortumab vedotin (Drug)
TRIDA Cohort
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
Intervention: darolutamide (Drug)
NIADY Cohort
Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023
Intervention: Nivolumab monotherapy (Drug)
Outcomes
Primary Outcomes
Progresion-free survival rate at 18 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported