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

Completed

• Conditions: Metastatic Castration-Resistant Prostate Cancer
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Other standard care

• Registration Number: NCT04256993
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Study Start: 2020-02-15
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1434

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ra-223 initiators	Radium-223 dichloride (Xofigo, BAY88-8223)	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.
Initiators of other standard of care	Other standard care	The comparator cohort will be patients using standard of care other than Ra-223.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Database Study; 🇸🇪 Database Study, Sweden