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

Bayer

Status: Completed

Conditions: Metastatic Castration-Resistant Prostate Cancer

Treatments: Drug: Other standard care; Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study type: Observational

Funder types: Industry

Identifiers

NCT04256993

20437

Details and patient eligibility

About

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).

Enrollment: 1,434 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

1,434 participants in 2 patient groups

Ra-223 initiators

Description:

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.

Treatment:

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Initiators of other standard of care

Description:

The comparator cohort will be patients using standard of care other than Ra-223.

Treatment:

Drug: Other standard care