Treatment Satisfaction With Ra-223 in Japan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment Satisfaction With Ra-223 Among Japanese Castration Resistant Prostate Cancer (CRPC) Patients

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bone metastatic CRPC patients<br>Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Changes in the MAX-PC scores will be analyzed as full scores (no sub-domains). | 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). | 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. | 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. | From baseline to 7 months | 
| Differences in change in bone pain (measured by FACT-BP) between potential subgroups | Potential subgroups will be identified depending on the number of patients available for subgrouping. | From baseline to 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Castration resistant prostate cancer, Patient reported outcome