Treatment Satisfaction With Ra-223 Among Japanese Castration Resistant Prostate Cancer (CRPC) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bone metastatic CRPC patients
Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
时间窗: From baseline to 7 months
The CTSQ is a 16-item self-administered questionnaire measuring 3 domains related to patients' satisfaction with cancer therapy.
次要结局
- Change in the total scores of the CTSQ domains(From baseline to 7 months)
- Differences in change in treatment satisfaction (measured by CTSQ) between potential subgroups(From baseline to 7 months)
- Differences in change in prostate cancer anxiety (measured by MAX-PC) between potential subgroups(From baseline to 7 months)
- Differences in change in bone pain (measured by FACT-BP) between potential subgroups(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)
- 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)