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Observing the effectiveness of funded drugs for genitourinary cancers

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

Observational Spanish Oncology Genito-Urinary Group · NCT06724159

This study looks at how well new cancer drugs work for patients with genitourinary tumors in Spain by collecting real-life data from their treatment experiences.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorSpanish Oncology Genito-Urinary Group Academic / other
Locations84 sites (Albacete, Albacete and 83 other locations)
Trial IDNCT06724159 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of genitourinary malignancies who have started treatment with recently funded medications.

Not a fit: Patients who began treatment before January 1, 2023, or those not receiving treatment at participating centers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of new cancer treatments in real-world settings, potentially improving patient outcomes.

How similar studies have performed: Other observational studies have shown success in validating treatment effectiveness in real-world settings, making this approach promising.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Albacete, Albacete and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Genitourinary CancersUrothelial carcinomaProstate adenocarcinomaRenal carcinomaDarolutamidaNivolumabEnfortumab Vedotin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.