Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Clinical trial
Clinical trials

Clinical trial regulatory scope

Post-authorisation interventional clinical trial

Clinical trial phase

Therapeutic use (Phase IV)

Clinical trial randomisation

Non-randomised clinical trial

Clinical trial types

Single-arm trial
Study drug and medical condition

Name of medicine

XTANDI

Medical condition to be studied

Metastases to prostate
Population studied

Short description of the study population

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Enzalutamide Who Are at Potential Increased Risk of Seizure.

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)

Special population of interest

Other

Special population of interest, other

Prostate Cancer patients

Estimated number of subjects

400
Study design details

Main study objective

To evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in subjects with metastatic castration-resistant prostate cancer known to have risk factor(s) for seizure.

Outcomes

The proportion of evaluable subjects with at least one confirmed seizure as adjudicated by the Independent Adjudication Committee (IAC) during the 4-month treatment duration.

Data analysis plan

All data will be summarized with descriptive statistics (number of subjects, mean, standard deviation, minimum, median and maximum) for continuous endpoints, and frequency and percentage for categorical endpoints.