Incidence of Second primary Malignancies in prostate Cancer patients with bone metastases – an observational retrospective cohort study in Sweden (SMARCOS)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Background incidence study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Second primary malignancy

Population studied

• Short description of the study population:
  Patients with prostate cancer having diagnosis in 1.1.1998 – 31.12.2013 and with bone metastases diagnosis or bone-directed treatments in 1.1.1998 – 31.12.2013 will be initially included into the large study population.
• 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:
  15000

Study design details

• Main study objective:
  To evaluate the incidence of developing any second primary malignancy among prostate cancer patients with bone metastases (mPC) and among a subgroup of mPC patients whom the prostate cancer is castration-resistant (mCRPC).
• Outcomes:
  incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48. 1.Incidences of any site-specific second primary malignancies2.Overall survival3.Pathologic fracture4.Spinal cord compression5.Surgery to bone6.Radiation to bone
• Data analysis plan:
  Characteristics of study subjects at cohort entry will be described. The incidence rate (and its 95% Confidence Interval) of any second primary malignancies will be calculated as a ratio of the number of incident cases and total follow-up time. Overall survival will be studied as time from cohort entry to death due to any cause. The survival time will be described with summary statistics. Yearly survival rates and Kaplan-Meier survival curves will be reported. Details on analysis will be described in the Statistical Analysis Plan (SAP).