check_circleStudy Completed

Castration-resistant prostate cancer

Bayer Identifier:

21124

ClinicalTrials.gov Identifier:

NCT04232761

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

Male

Age

NaN - N/A
  • - 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
  • - 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
194
Trial Dates
July 2020 - April 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Taiwan

Primary Outcome

  • Incidence of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 7 months
  • Incidence of drug-related TEAEs
    date_rangeTime 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.
    date_rangeTime Frame:
    Up to 2 years

Secondary Outcome

  • Overall survival
    date_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) response
    ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase
    date_rangeTime Frame:
    Up to 2 years
  • Proportion of patients with PSA response
    PSA - Prostate Specific Antigen
    date_rangeTime 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)
    date_rangeTime 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).
    date_rangeTime Frame:
    Up to 2 years

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
N/A

Additional Information

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