Clinical trial · Observational
Treatment Satisfaction With Ra-223 in Japan
Treatment Satisfaction With Ra-223 Among Japanese Castration Resistant Prostate Cancer (CRPC) Patients
NCT03315260CI-TRIAL-00073832completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bone metastatic CRPC patients
- description
- Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Primary outcomes (1)
- measure
- Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
- timeFrame
- From baseline to 7 months
- description
- The CTSQ is a 16-item self-administered questionnaire measuring 3 domains related to patients' satisfaction with cancer therapy.
Secondary outcomes (6)
- measure
- Change in the total scores of the CTSQ domains
- timeFrame
- From baseline to 7 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDAkakura K, Uemura H, Kawakami S, Yokomizo A, Nakamura M, Nishimura K, Komori T, Ledesma DA. Metastatic castration resistant prostate cancer patients' experience with Radium-223 treatment in Japan. Future Oncol. 2024 Apr;20(12):781-798. doi: 10.2217/fon-2023-0870. Epub 2024 Jan 26. PMID 38275149