Castration-resistant Prostate Cancer
Conditions
Keywords
Bone metastases, Radium-223 dichloride
Brief summary
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).
Detailed description
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.
Interventions
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)
Drug administration as determined by treating physician
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 7 months | — |
| Incidence of drug-related TEAEs | Up to 7 months | — |
| Descriptive analysis of long-term safety information during the extended follow-up period | Up to 2 years | This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first symptomatic skeletal event (SSE) | Up to 2 years | — |
| Change in ECOG-PS | Up to 2 years | The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death). |
| Proportion of patients with PSA response | Up to 2 years | PSA - Prostate Specific Antigen |
| Proportion of patients with total ALP (tALP) response | Up to 2 years | ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase |
| Change in pain status | Up to 2 years | 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) |
| Overall survival | Up to 2 years | — |
Countries
Taiwan
Outcome results
None listed