Treatment Satisfaction With Ra-223 in Japan
Study Details
Study Description
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 patient anxiety regarding prostate cancer while on treatment with Ra-223, and assess the effect on quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 patients on 1st to 3rd line CRPC therapy. All outcomes will be obtained using PRO questionnaires at 4 time points: before treatment, during treatment, and at 1-month after the last treatment cycle.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Bone metastatic CRPC patients Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement |
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)
|
Outcome Measures
Primary Outcome Measures
- Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ) [From baseline to 7 months]
The CTSQ is a 16-item self-administered questionnaire measuring 3 domains related to patients' satisfaction with cancer therapy.
Secondary Outcome Measures
- Change in the total scores of the CTSQ domains [From baseline to 7 months]
- Change in patient anxiety with prostate cancer using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [From baseline to 7 months]
Changes in the MAX-PC scores will be analyzed as full scores (no sub-domains).
- Change in bone-related symptoms using the Functional Assessment of Cancer Therapy Quality of Life Measurement in Patients with Bone Pain (FACT-BP) [From baseline to 7 months]
Change in FACT-BP scores will be analyzed as full scores (no subdomains).
- Differences in change in treatment satisfaction (measured by CTSQ) between potential subgroups [From baseline to 7 months]
Potential subgroups will be identified depending on the number of patients available for subgrouping.
- Differences in change in prostate cancer anxiety (measured by MAX-PC) between potential subgroups [From baseline to 7 months]
Potential subgroups will be identified depending on the number of patients available for subgrouping.
- Differences in change in bone pain (measured by FACT-BP) between potential subgroups [From baseline to 7 months]
Potential subgroups will be identified depending on the number of patients available for subgrouping.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥20 years old (age of maturity in Japan)
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Male, diagnosed with CRPC
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With ≥2 bone metastases and no visceral metastasis based on the most recent imaging procedure
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Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1, not in end-stage palliative care
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Designated by examining physician to undergo Ra-223 treatment either in the 1st, 2nd, or 3rd line of CRPC therapy
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Has provided written, informed consent (in Japanese)
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Has ≥6 months life expectancy
Exclusion Criteria:
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Participation in an investigational program with interventions outside of routine clinical practice
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Currently receiving any chemotherapy for CRPC or any new hormone therapy (enzalutamide, abiraterone acetate) at enrolment
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Where any of the below conditions apply:
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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
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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
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Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the previous 24 weeks
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Previous hemi-body external radiotherapy
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Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
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Presence of other maligancy at enrolment
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Otherwise deemed incapable of participating by examining physician
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Multiple Locations | Japan |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19502