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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04256993

Acronym

PRECISE

Enrollment

1434

Registered

2020-02-05

Start date

2020-02-15

Completion date

2021-06-01

Last updated

2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-Resistant Prostate Cancer

Keywords

Prostate cancer metastatic, Prostate cancer, Bone fractures, Overall survival

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).

Interventions

DRUGRadium-223 dichloride (Xofigo, BAY88-8223)

Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs.

DRUGOther standard care

Docetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026