Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone

Bayer194 enrolled

Overview

In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan. The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.

Study Type

OBSERVATIONAL

Enrollment

194

Conditions

Castration-resistant Prostate Cancer

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)DRUG

Drug administration as determined by treating physician

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases * Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator * No contra-indications according to the local marketing authorization Exclusion Criteria: * Previously treated with Radium-223 for any reason * Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time frame: Up to 7 months

Incidence of drug-related TEAEs

Time frame: Up to 7 months

Descriptive analysis of long-term safety information during the extended follow-up period

This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.

Time frame: Up to 2 years

Secondary Outcomes

Overall survival

Time frame: Up to 2 years

Time to the first symptomatic skeletal event (SSE)

Time frame: Up to 2 years

Proportion of patients with total ALP (tALP) response

ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase

Time frame: Up to 2 years

Proportion of patients with PSA response

PSA - Prostate Specific Antigen

Time frame: Up to 2 years

Change in pain status

Pain status is assessed through analgesic utility that is calculated by WHO analgesic scores (0 - none, 1 - non-opioid, 2 - opioid for mild to moderate pain, 3 - opioid for moderate to severe pain)

Time frame: Up to 2 years

Change in ECOG-PS

The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death).

Time frame: Up to 2 years

Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes