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

Sponsor
Spanish Oncology Genito-Urinary Group
Study ID
NCT06724159
Status
Recruiting
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Conditions

  • Genitourinary Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Dec 13, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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
  • Arm: NIADY Cohort
    Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023
  • Arm: EV3aL Cohort
    Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024

Primary Outcome Measure

Progresion-free survival rate at 18 months [ Time Frame: 18 months after the initiation of study treatment ]

Central Contacts