Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation
Healthcare resource utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name

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

Hormone-dependent prostate cancer
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 Europe 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

600
Study design details

Study design

This study will use information collected from medical centers in Europe of men who started ARPI treatment from Jan2020 until about Dec2024. This study is about collecting information only. The individual’s doctor decides on treatment, not the study sponsor (Astellas).

Main study objective

In Part 1 the main aim is to compare the profile of the men treated with enzalutamide with the men treated with other ARPIs. Information such as the men’s age when ARPI treatment began, the date of prostate cancer diagnosis, previous prostate cancer treatments or procedures, and health status will be collected.

In Part 2 the main aim is to compare how long the men are treated with enzalutamide compared with other ARPIs. Information such as when treatment stops will be collected.

Outcomes

Primary
• Baseline characteristics:
Physician characteristics
o Specialty (e.g., urologist, oncologist)
o Practice setting (e.g., academic institution, community practice, private practice)
• Demographics:
o Age at index (i.e., date of treatment initiation with ARPI)
o Country
o Participating any prospective non-interventional studies (yes/no)
• Clinical characteristics as of the index date (if available):
o Year of initial PC diagnosis
o Performance status (e.g., ECOG)
o Comorbidities
o Tumor grade (Gleason score)
o Disease volume status (high/low); type of imaging used (bone scan, CT scan MRI, or PSMA-PET)
o Disease risk status (high/low); type of imaging used (bone scan, CT scan MRI, or PSMA-PET)
o De novo vs. recurrent status
o For recurrent patients
-Prior treatments (surgery/radiation, NSAA)
-Prior exposure to ADT (yes/no)
-Time from definitive therapy to index
o Site of metastasis
-Visceral metastasis (yes/no)
-Liver metastasis in patients with visceral disease (yes/no)
-Bone metastasis (yes/no)
-Lymph node metastasis (yes/no)
-Other metastasis (yes/no)
o PSA value measured closest to and within 180 days prior to index or initiation of ADT, whichever comes first
o Mean/median testosterone measured prior to index (if available)
o Conventional imaging vs PSMA-PET vs both for diagnosis of mHSPC, disease response, and progression monitoring
o Year of ARPI treatment initiation
o Time between mHSPC diagnosis and ARPI initiation
o Time between ADT and ARPI initiation

Data analysis plan

Baseline characteristics will be reported using descriptive statistics, including means (with standard deviations (SDs), medians (with interquartile ranges (IQRs)), minimum and maximum for continuous variables, as well as counts and proportions for categorical variables.