Observational Study of Patients Treated with New Available Formulation of Enantone in Prostate Cancer (ONE)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Longitudinal study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LEUPRORELIN
• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Patients with prostate cancer who are initiating Enantone 3.75 milligram (mg), 11.25 mg, or 30 mg in pre-filled syringe under standard regular care.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 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:
  200

Study design details

• Main study objective:
  The primary objective of this study is to assess treatment satisfaction in patients initiating Enantone new formulation for prostate cancer.
• Outcomes:
  The primary outcomes will assess the satisfaction of patients through TSQM. The secondary outcomes will assess the satisfaction of nurses through visual analogue scale (VAS), characteristics of patients, hot flushes, healthcare resource utilization.
• Data analysis plan:
  Descriptive analysis will be performed of all collected data except data collected only for the purpose of data cleaning. Descriptive analysis of qualitative and ordinal variables will comprise the mean, standard deviation and their confidence intervals as well as the median and range. Univariate analysis will be performed on data from case report form (CRF) and questionnaire.