A multicentre, non-interventional, cohort analysis describing the patients’ experience focusing on safety events among metastatic hormone-sensitive prostate cancer patients treated with Androgen Receptor Pathway Inhibitors (ARPIs) followed through a Telemonitoring tool funded by the French national healthcare insurance complemented with a chart review (ESPERANTO)

Study identification

• EU PAS number:
  EUPAS1000000759
• Study ID:
  1000000759
• Official title and acronym:
  A multicentre, non-interventional, cohort analysis describing the patients’ experience focusing on safety events among metastatic hormone-sensitive prostate cancer patients treated with Androgen Receptor Pathway Inhibitors (ARPIs) followed through a Telemonitoring tool funded by the French national healthcare insurance complemented with a chart review (ESPERANTO)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Currently, there is a significant lack of real-world data regarding the use, tolerability, and patient experiences during ARPI treatment. ; The data that exists is often collected from databases that rely on using proxies for the patient experience such as claims or physician notes. ; While this approach can convey valuable information it may not fully represent the patient experience.; ; This study offers a unique and innovative approach to understanding the patients experience by leveraging the Cureety remote monitoring platform to collect information directly from the patient perspective without proxies. The dual approach of also leveraging the charts allows for collection of disease specific factors which are best identified from clinicians and also collection of additional data such as treatment duration. This dual data collection strategy—leveraging both the Cureety remote monitoring platform and patient medical records—will yield a richer, more nuanced understanding of the mHSPC patient experience during ARPI treatment.
• Study status:
  Planned

Research institutions and networks

Institutions

Astellas Pharma Europe Ltd.

Study timelines

Date when funding contract was signed

Actual:21/05/2025

Study start date

Planned:31/10/2025

Data analysis start date

Planned:28/02/2026

Date of final study report

Planned:31/05/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe Ltd.

Regulatory

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

Other study registration identification numbers and links

9785-MA-3673