check_circleStudy Completed
Castration-resistant prostate cancer
Bayer Identifier:
21124
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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).
Key Participants Requirements
Sex
MaleAge
NaN - N/ATrial summary
Enrollment Goal
194Trial Dates
July 2020 - April 2024Phase
Phase 4Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Taiwan |
Primary Outcome
- Incidence of treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to 7 months
- Incidence of drug-related TEAEsdate_rangeTime Frame: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.date_rangeTime Frame:Up to 2 years
Secondary Outcome
- Overall survivaldate_rangeTime Frame:Up to 2 years
- Time to the first symptomatic skeletal event (SSE)date_rangeTime Frame:Up to 2 years
- Proportion of patients with total ALP (tALP) responseALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatasedate_rangeTime Frame:Up to 2 years
- Proportion of patients with PSA responsePSA - Prostate Specific Antigendate_rangeTime Frame: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)date_rangeTime Frame: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).date_rangeTime Frame:Up to 2 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A