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NCT Number: NCT06724159

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

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.

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Key information

Conditions

Genitourinary Cancers Adenocarcinoma Carcinoma Carcinoma, Renal Cell Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Albacete, Albacete, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darolutamide

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

A Responsible Person Designated by the sponsor

CONTACT

[email protected]

0034934344412

Sponsors and collaborators

Lead sponsor

Spanish Oncology Genito-Urinary Group

Other

Collaborators

  • MFAR

Registry information

Official study title

PRINCIS Study ("Public Health Clinical Research Project"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.

Acronym: SOGUG-PRINCIS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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