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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XTANDI
• Study drug International non-proprietary name (INN) or common name:
  ENZALUTAMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (L02BB04) enzalutamide

  enzalutamide
• Medical condition to be studied:
  Prostate cancer metastatic
• Additional medical condition(s):
  metastatic hormone-sensitive prostate cancer (mHSPC)

Population studied

• Short description of the study population:
  Prostate cancer affects the prostate gland in men and needs male sex hormones such as testosterone, to grow. Androgen receptor pathway inhibitors (ARPIs) are a type of hormone therapy used to treat men with prostate cancer. They work by reducing the amount of testosterone in the body. The ARPIs are usually given with other prostate cancer treatments.; ; This study is for men in France who are treated with ARPIs for their prostate cancer. The men have metastatic hormone-sensitive prostate cancer (mHSPC). Metastatic means the cancer has spread to other parts of the body. Hormone sensitive means the cancer needs male sex hormones such as testosterone to grow. ;
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  950

Study design details

• Study design:
  Study design: French, multicenter, non‐interventional cohort study with secondary data. Review of medical records of participants/participant-reported events from French medical centers from Jul 2019-Sep 2026. Study for collecting information only. Individual’s doctor decides treatment, not sponsor.
• Main study objective:
  The main aims of this study are to collect safety information on different ARPIs given to men with mHSPC in France. Other aims are to learn how long the men use ARPIs, if they tolerate treatment and reasons for stopping treatment.
• Outcomes:
  Primary; • Rate of treatment discontinuation due to Adverse Events (AEs).
• Data analysis plan:
  AE rates will be calculated overall and for each ARPI along with the 2-sided 95% CI using the Clopper-Pearson method (exact CI for a binomial proportion as computed by default by the FREQ procedure using the EXACT option). For rates per person-year, Poisson regression or negative binomial (GENMOD) will be considered.