Treatment Satisfaction With Ra-223 in Japan

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT03315260
• Lead Sponsor: Bayer

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Study Start: 2019-04-11
• Primary Completion: 2022-12-01
• Study Completion: 2023-03-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 85

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone metastatic CRPC patients	Radium-223 dichloride (Xofigo, BAY88-8223)	Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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.
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).

Trial Locations

Locations (1)

Many Locations; 🇯🇵 Multiple Locations, Japan