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.
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 Type
OBSERVATIONAL
Enrollment
85
Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)
Many Locations
Multiple Locations, Japan
Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
The CTSQ is a 16-item self-administered questionnaire measuring 3 domains related to patients' satisfaction with cancer therapy.
Time frame: From baseline to 7 months
Change in the total scores of the CTSQ domains
Time frame: From baseline to 7 months
Change in patient anxiety with prostate cancer using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Changes in the MAX-PC scores will be analyzed as full scores (no sub-domains).
Time frame: From baseline to 7 months
Change in bone-related symptoms using the Functional Assessment of Cancer Therapy Quality of Life Measurement in Patients with Bone Pain (FACT-BP)
Change in FACT-BP scores will be analyzed as full scores (no subdomains).
Time frame: From baseline to 7 months
Differences in change in treatment satisfaction (measured by CTSQ) between potential subgroups
Potential subgroups will be identified depending on the number of patients available for subgrouping.
Time frame: From baseline to 7 months
Differences in change in prostate cancer anxiety (measured by MAX-PC) between potential subgroups
Potential subgroups will be identified depending on the number of patients available for subgrouping.
Time frame: From baseline to 7 months
Differences in change in bone pain (measured by FACT-BP) between potential subgroups
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Potential subgroups will be identified depending on the number of patients available for subgrouping.
Time frame: From baseline to 7 months