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)
Bayer Identifier:
21124
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 | |
|---|---|
Locations Many locations Many locations, Taiwan, China | 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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