Prospective observational study to describe routine use of XGEVAâ for prevention of skeletal related events (SREs) in subjects with bone metastases from prostate carcinoma in Bulgaria (20180095)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Routine use of XGEVA® for prevention of skeletal related events (SREs) in subjects with bone metastases from prostate carcinoma
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicentre, prospective, observational study

Study drug and medical condition

• Name of medicine:
  XGEVA
• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Adult patients aged 18 years or older diagnosed with bone metastases from hormone-sensitive prostate carcinoma (HSPC) and castrate-resistant prostate carcinoma (CRPC) received treatment with XGEVA® in routine clinical practice between January 2019 to January 2021 in Bulgaria.; Inclusion Criteria:; I. Patient at least 18 years old at the time of ICF signature; II. Patient with histologically or cytologically confirmed diagnosis of prostate carcinoma with at least one bone metastasis lesion confirmed by imaging (X-ray, MRI, or CT); III. Patient received between one and three XGEVA® administrations in the timeframe of six months prior to enrolment; IV. Patient provided written informed consent; ; Exclusion Criteria:; I. Patient with bone metastases previously treated in the last six months with bisphosphonates or other bone-targeting agents (BTAs) for prevention of SREs in clinical trial or routinely; II. Patient with prostate carcinoma as a second primary malignancy; III. Patient with brain metastases; IV. Patient currently enrolled in trial with investigational drug for treatment/prevention of bone metastases and SREs
• 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:
  Patients with bone metastases
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The primary objective of the study is to describe real life patterns of bone metastases management and routine use of XGEVA® for SREs prevention in subjects with bone metastases from prostate carcinoma.
• Outcomes:
  Demographic and clinical characteristics of subjects with bone metastases from HSPC and CRPC receiving XGEVA® in clinical routine practice. Treatment patterns. Estimate the incidence of SREs and symptomatic SREs (SSEs) in patients with bone metastases from hormone sensitive and CRPC. Describe patient and/or physician reported factors that influence adherence to treatment based on data obtained via specific questionnaires, namely: Beliefs about medicines questionnaire (BMQ)
• Data analysis plan:
  The analysis of this study will be descriptive in nature. Counts and percentages will be provided for categorical outcomes. Continuous outcomes will be summarized by the number of non-missing values, mean, standard deviation, median, lower and upper quartiles and minimum and maximum values. Cumulative incidence for SREs will be analysed with Andersen-Gill method for recurrent events, treating death as competing risk. For each outcome parameter, the impact of covariates will be assessed using generalized linear models, when appropriate. The detailed description of covariates and subgroups analysis will be enclosed to the Statistical Analysis Plan (SAP). If available, non-significant factors will be eliminated stepwise until only covariates significant at the 5% level remain, thereby indicating which covariates have an important influence on treatment pattern. The final decision about removing or keeping the variable from the analysis will be taken based on the medical knowledge of spon

Documents

Study results

20180095 01.47.01.01 Observational Research Study Report Published Report_Redacted