Status:
COMPLETED
Treatment Satisfaction With Ra-223 in Japan
Lead Sponsor:
Bayer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
20+ years
Brief Summary
This study aims to answer the research question: Are Japanese bone metastatic CRPC patients satisfied with their Ra-223 treatment, and what factors drive such satisfaction? It also aims to determine p...
Detailed Description
This is a local, Japanese, prospective, longitudinal, observational, company-sponsored, multi-center, single arm study that will describe treatment satisfaction with Ra-223 in 150 bone metastatic CRPC...
Eligibility Criteria
Inclusion
- Age ≥20 years old (age of maturity in Japan)
- Male, diagnosed with CRPC
- With ≥2 bone metastases and no visceral metastasis based on the most recent imaging procedure
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1, not in end-stage palliative care
- Designated by examining physician to undergo Ra-223 treatment either in the 1st, 2nd, or 3rd line of CRPC therapy
- Has provided written, informed consent (in Japanese)
- Has ≥6 months life expectancy
Exclusion
- Participation in an investigational program with interventions outside of routine clinical practice
- Currently receiving any chemotherapy for CRPC or any new hormone therapy (enzalutamide, abiraterone acetate) at enrolment
- Where any of the below conditions apply:
- Started or switched to new androgen deprivation therapy (ADT) (e.g., LHRH agonists and antagonists, anti-androgens, estrogens,) within 4 weeks prior to enrolment or planning to start new treatment prior to 1st Ra-223 injection
- Treatment with anticancer-chemotherapy within previous 4 weeks, or planned before the 1st Ra-223 injection, or failure to recover from adverse events (AEs) (CTCAE Grade \>2) due to anticancer chemotherapy administered more than 4 weeks prior
- Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the previous 24 weeks
- Previous hemi-body external radiotherapy
- Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
- Presence of other maligancy at enrolment
- Otherwise deemed incapable of participating by examining physician
Key Trial Info
Start Date :
April 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03315260
Start Date
April 11 2019
End Date
March 20 2023
Last Update
February 8 2024
Active Locations (1)
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1
Many Locations
Multiple Locations, Japan