Trial Condition(s):

Prostatic Neoplasms

Treatment satisfaction with Ra-223 in Japan

Bayer Identifier:

19502

ClinicalTrials.gov Identifier:

NCT03315260

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

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 patient anxiety regarding prostate cancer while on treatment with Ra-223, and assess the effect on quality of life.

Inclusion Criteria
-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 Criteria
- 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

Trial Summary

Enrollment Goal
150
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Japan

Status
Recruiting
 

Trial Design