Use of degarelix among patients with prostate cancer in daily practice

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Historical cohort database study

Study drug and medical condition

• Name of medicine:
  FIRMAGON

Population studied

• Short description of the study population:
  Patients with prostate cancer who are new users of degarelix, leuprorelin, goserelin or triptorelin and are registered at a general practice from 2010 till present.; Inclusion criteria:; • Evidence of prostate cancer: an ever diagnostic code (Quality Outcomes Framework (QOF) defined) for prostate cancer or a diagnostic code for surgery, chemotherapy or radiotherapy plus a prescription of degarelix, leuprorelin, goserelin or triptorelin before or at IPD;; • Patients who have at least one record of degarelix, leuprorelin, goserelin or triptorelin;; • Each patient has to be registered with a general practitioner (GP) for at least one year before the IPD;; • Patients have to be actively registered from 2010 till present, i.e. until latest available data
• Age groups:
  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:
  8825

Study design details

• Main study objective:
  The aim of the study is to describe the use of degarelix among patients with prostate cancer in UK’s primary care.
• Outcomes:
  the number of ‘switchers’ to second line treatment (leuprorelin, goserelin, triptorelin or degarelix), cardio events and urinary tract infections from the year 2010 till present.
• Data analysis plan:
  An exploratory analysis of variables at baseline or during follow-up (switching to second line treatment, cardio events, or urinary tract infections) will be carried out:Results are reported as: ● Continuous variables:o Sample size (n) (standard deviation (SD)) and percentage non-missingo Median and Interquartile Range (25th and 75th percentiles)● Categorical variables:o Sample size (n) and percentage non-missingo Count and percentage by category (distribution)