Utilization patterns of oral therapies in prostate cancer in Tuscany: a retrospective observational study based on regional administrative databases

Study summary

Study identification

• EU PAS number:
  EUPAS1000001049
• Study ID:
  1000001049
• Official title and acronym:
  Utilization patterns of oral therapies in prostate cancer in Tuscany: a retrospective observational study based on regional administrative databases
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Background: Prostate cancer is one of the most common cancers among men worldwide. The introduction of second-generation androgen receptor inhibitors (ARIs) has substantially changed the treatment of prostate cancer across different disease settings. Given their increasing use in clinical practice and the limited availability of real-world evidence on utilization patterns and clinically relevant outcomes, further evaluations based on administrative healthcare data are warranted.; Objectives: The primary objective of this study is to describe the utilization patterns of oral therapies for prostate cancer in Tuscany, with particular focus on abiraterone, apalutamide, enzalutamide, and darolutamide. Secondary objectives are to characterize the demographic and clinical profile of treated patients, describe treatment discontinuation and switching patterns, and evaluate the occurrence of major cardiovascular and other clinically relevant adverse events associated with these therapies.; Methods: This is a retrospective descriptive observational cohort study based on the regional administrative healthcare databases of Tuscany. All residents of Tuscany aged ≥18 years with at least one dispensing of abiraterone, apalutamide, enzalutamide, or darolutamide between 2016 and 2025 will be included. Patients will be classified as first-line users, new users beyond first-line therapy, or prevalent users. Drug utilization patterns will be described according to calendar year and Regional Healthcare Area. Demographic and clinical characteristics, including comorbidities and concomitant medications, will be evaluated among first-line users and new users beyond first-line therapy. Treatment discontinuation, treatment switching, and clinically relevant adverse events resulting in hospitalization or emergency department visits, including cardiovascular events, acute kidney injury, acute liver injury, and fractures, will be evaluated during follow-up using validated algorithms.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Pisa

Unit of adverse drug reactions monitoring (UADRM), University Hospital of Pisa

Italy

Agenzia regionale di sanità della Toscana (ARS Toscana)

Italy

University of Siena

Department of Statistics, Informatics and Applications 'Giuseppe Parenti', University of Florence.

Italy

Networks

Centro Regionale di Farmacovigilanza della Toscana (CRFVT)

Italy

Study timelines

Date when funding contract was signed

Actual:01/04/2026

Study start date

Planned:06/07/2026

Actual:01/01/2016

Data analysis start date

Planned:06/07/2026

Date of final study report

Planned:30/09/2026

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable