Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) PatiEnts Treated With Radium 223 in Routine Clinical practIce in SwedEn
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 1,434
- Locations
- 1
- Primary Endpoint
- Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
Study Overview
Brief Summary
In this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. The goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Ra-223 treatment for mCRPC as an n-th line of treatment, where "n" goes from 1 to
- •ECOG 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.
Exclusion Criteria
- •Prior use of Ra-223
- •Patients that have participated in a Ra-223 RCT
Arms & Interventions
Ra-223 initiators
Patients diagnosed with mCRPC (Metastatic Castration-Resistant Prostate Cancer) who start treatment with Ra-223. Patients will be identified from the "Patient-overview Prostate Cancer" (PPC), a sub-registry of the Prostate Cancer data Base Sweden (PCBaSe) data set.
Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
Initiators of other standard of care
The comparator cohort will be patients using standard of care other than Ra-223.
Intervention: Other standard care (Drug)
Outcomes
Primary Outcomes
Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
Time Frame: Retrospectively analysis from November 2013 to December 2018
PCBaSe: Prostate Cancer data Base Sweden
Secondary Outcomes
- Death due to all causes(Retrospectively analysis from November 2013 to December 2018)
- Death due to prostate cancer(Retrospectively analysis from November 2013 to December 2018)