Drug utilisation study of Radium 223 under routine clinical practice in Europe (DIRECT)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Xofigo
• Study drug International non-proprietary name (INN) or common name:
  RADIUM RA 223 DICHLORIDE
• Medical condition to be studied:
  Prostate cancer metastatic

  Metastases to bone

Population studied

• 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)
• Estimated number of subjects:
  850

Study design details

• Main study objective:
  The main objective is to estimate, among the population of patients receiving radium-223, the proportion who receive radium-223 in combination with abiraterone acetate, the proportion who receive radium-223 in combination with other systemic therapies for mCRPC, and the proportion who receive radium-223 without having received at least two prior lines of systemic therapy for mCRPC.
• Outcomes:
  1) use of radium-223 in combination with abiraterone acetate 2) use of radium-223 in combination with other systemic therapies for mCRPC (except LHRH analogues) 3) use of radium-223 among patients who have not received at least two previous systemic therapies for mCRPC. The difference between before and after label change in each of primary objective measures, Age, Calendar year, Time since first diagnosis, Confirmed diagnosis of mCRPC, Prior use systemic therapy, Presence of metastasis at baseline: bone or visceral, Total level of serum alkaline phosphatase, Prior use of bone-health agents, Prior use of systemic corticosteroids and History of osteoporosis.
• Data analysis plan:
  The main analysis will estimate the proportion of patients who used (1) radium-223 in combination with abiraterone acetate for mCRPC, (2) radium-223 in combination with other systemic therapies for mCRPC, and (3) radium-223 in the first line or second line of therapy without having received at least two previous therapies for mCRPC. The denominator for the proportions is the total number of new users of radium-223 during the study period (p), in each country-specific data source. The secondary analysis will (4) estimate the difference in these proportions before and after the label change and (5) describe the baseline variables in the study population (all users of radium-223, irrespective of combination therapies) during the study periods, using standard descriptive statistics (e.g. mean, median, and standard deviation for continuous variables and number and proportion for categorical variables).

Documents

Study results

20702_EU PAS Abstract_Redacted_V0.3_2023-06-01

Study report

20702_Study Report_Redacted_V0.3_2023-06-01