PRECISE/Rates of bone fractures and survival in metastatic castration-resistant PRostate cancer (mCRPC) PatiEnts treated with Radium-223 in routine Clinical practIce in SwedEn

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Population comprises men with mCRPC in the PCBaSe data set during the study time frame. No sampling will be performed.; The selection criteria have been chosen to select a population as similar as possible to the one; included in the ALSYMPCA and ERA 223 trials.; ; • Inclusion criteria (all of the following must be present):; • Histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the NPCR (histology other than adenocarcinomas are not registered in the NPCR).; • Start of any systemic treatment for mCRPC as an nth line of treatment, where n goes from 1 to 4. The following will be considered systemic treatment for mCRPC: Ra-223, docetaxel, cabazitaxel, enzalutamide, abiraterone, and the following group of less commonly used drugs in Sweden, which will be labelled as “others”—cisplatin, cyclophosphamide, doxorubicin, estramustine, etoposide, gemcitabine, carboplatin, methotrexate, mitoxantrone.; • Prostate cancer progression to ADT or subsequent lines of therapy. Prostate cancer progression will be surrogated by the initiation of a drug specific for mCRPC in the first or later lines of treatment.; • Eastern Cooperative Oncology Group performance status of 0-2 at treatment initiation.; We will assume that patients starting any of the systemic therapies under study have a performance status of 0-2.; • Presence of bone metastasis. We will assume that all patients receiving Ra-223 have bone metastasis and will select for the comparator group those with recorded bone metastasis.; ; • Exclusion criterion (includes either of the following):; • Prior use of Ra-223; • Patients that have participated in a Ra-223 RCT
• 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:
  3800

Study design details

• Main study objective:
  The primary objective in this study is to estimate the effect of Ra-223 on the incidence of bone fractures compared with other standard treatments for mCRPC.
• Outcomes:
  1. Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe。, 1. Death due to all causes 2. Death due to prostate cancer
• Data analysis plan:
  The primary outcome will be the incidence of bone fractures. The numerator will be the number of symptomatic bone fractures identified during Ra-223 use, and the denominator will be the sum of all person-years of follow-up for symptomatic bone fractures. The secondary outcomes are death due to all causes and death due to prostate cancer. The cumulative incidence of bone fractures, all-cause mortality, and prostate cancer–specific mortality will be estimated using the Kaplan-Meier estimator, and 95% confidence intervals will be computed using Greenwood’s formula.