Observing the effectiveness of funded drugs for genitourinary cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects data from patients with genitourinary tumors to evaluate the effectiveness of recently funded drugs under routine clinical practice in Spain. It includes both retrospective patient inclusion and prospective follow-up, focusing on drugs like darolutamide and nivolumab. The study aims to create a registry for genitourinary cancers and will open new subprojects for each newly authorized drug to validate endpoints from previous clinical trials. Treatment decisions are made independently of study participation, ensuring real-world applicability of the findings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Complejo Hospitalario Universitario de Albacete
  Albacete, Albacete, Spain Recruiting
• Hospital General Universitario de Alicante
  Alicante, Alicante, Spain Recruiting
• Hospital Universitario Torrecárdenas
  Almería, Andalusia, Spain Recruiting
• Hospital Universitario Reina Sofía
  Córdoba, Andalusia, Spain Recruiting
• Hospital Universitario Clínico San Cecilio
  Granada, Andalusia, Spain Recruiting
• Hospital Universitario Virgen a de las Nieves
  Granada, Andalusia, Spain Recruiting

+34 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: A Responsible Person Designated by the sponsor
• Email: investigacio@mfar.net
• Phone: 0034934344412

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study is testing a new treatment that uses specially modified immune cells from cancer patients to see if they can better target and shrink tumors in people with advanced cancer who haven't responded to regular treatments.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT03412877

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.