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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04256993
Other study ID # 20437
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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