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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Controlled, Partial-blind, Parallel-group Study Evaluating the Effect of Oral Administration of BAY 1834845 and BAY 1830839 Twice Daily for 7 Consecutive Days on Local and Systemic IRAK4 Pathway-related Challenges in Healthy Male Participants

Conditions
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Metastatic Castration-Resistant Prostate Cancer

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
* Drug: Other standard care


Participation Criteria
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Eligibility Criteria
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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 4. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ra-223 initiators<br>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. | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs.<br>|
| Initiators of other standard of care<br>The comparator cohort will be patients using standard of care other than Ra-223. | Drug: Other standard care<br>* Docetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe | PCBaSe: Prostate Cancer data Base Sweden | Retrospectively analysis from November 2013 to December 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer metastatic, Prostate cancer, Bone fractures, Overall survival