Trial Condition(s):
Castration-Resistant Prostate Cancer
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 (RAPIT)
Trial Purpose
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Many locations Many locations, Taiwan, China | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Safety and Effectiveness of Xofigo® (Radium-223 dichloride) in Routine Clinical Practice Settings in Taiwan
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of treatment-emergent adverse events (TEAEs)Timeframe: Up to 7 months
- Incidence of drug-related TEAEsTimeframe: Up to 7 months
- Descriptive analysis of long-term safety information during the extended follow-up periodThis safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.Timeframe: Up to 2 years
Secondary Outcome
- Overall survivalTimeframe: Up to 2 years
- Time to the first symptomatic skeletal event (SSE)Timeframe: Up to 2 years
- Proportion of patients with total ALP (tALP) responseALP - Alkaline Phosphatase tALP - Total Alkaline PhosphataseTimeframe: Up to 2 years
- Proportion of patients with PSA responsePSA - Prostate Specific AntigenTimeframe: Up to 2 years
- Change in pain statusPain 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)Timeframe: Up to 2 years
- Change in ECOG-PSThe Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death).Timeframe: Up to 2 years
Additional Information
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