check_circleStudy Completed
Metastatic Castration-Resistant Prostate Cancer
Bayer Identifier:
20437
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
PRECISE, a study 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
Trial purpose
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).
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
1434Trial Dates
February 2020 - June 2021Phase
Phase 4Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | database study | database study, Sweden |
Primary Outcome
- Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSePCBaSe: Prostate Cancer data Base Swedendate_rangeTime Frame:Retrospectively analysis from November 2013 to December 2018
Secondary Outcome
- Death due to all causesdate_rangeTime Frame:Retrospectively analysis from November 2013 to December 2018
- Death due to prostate cancerdate_rangeTime Frame:Retrospectively analysis from November 2013 to December 2018
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A