Treatment Satisfaction With Ra-223 in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-11

Study Completion Date

2023-03-20

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.

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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.

Conditions

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Prostatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone metastatic CRPC patients

Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)

Interventions

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Radium-223 dichloride (Xofigo, BAY88-8223)

Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No