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

Metastatic Castration-Resistant Prostate Cancer Clinical Trial

— PRECISE  

Official title:

Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) PatiEnts Treated With Radium 223 in Routine Clinical practIce in SwedEn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256993
• Other study ID #: 20437
• Status: Completed
• Start date: February 15, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1434
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Metastatic Castration-Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs.
• Other standard care
Docetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice.

Locations

Country	Name	City	State
Sweden	Database Study	Database Study

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death due to all causes		Retrospectively analysis from November 2013 to December 2018
Secondary	Death due to prostate cancer		Retrospectively analysis from November 2013 to December 2018

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