Trial Condition(s):

Metastatic castration-resistant prostate cancer

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 (PRECISE)

Bayer Identifier:

20437

ClinicalTrials.gov Identifier:

NCT04256993

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
1434
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

database study

database study, Sweden

Status
Completed
 

Trial Design