Study Completed

Prostatic Neoplasms

Bayer Identifier:

19502

ClinicalTrials.gov Identifier:

NCT03315260

EudraCT Number:

Not Available

EU CT Number:

Not Available

Treatment satisfaction with Ra-223 in Japan

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

20 - N/A

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

Trial summary

Enrollment Goal

Trial Dates

April 2019 - March 2023

Phase

Phase 4

Could I Receive a placebo

Products

Xofigo (Radium-223 dichloride, BAY88-8223)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Many Locations, Japan

Primary Outcome

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

Secondary Outcome

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
Potential subgroups will be identified depending on the number of patients available for subgrouping.
Time Frame:
From baseline to 7 months

Trial design

Treatment Satisfaction with Ra-223 among Japanese Castration Resistant Prostate Cancer (CRPC) Patients

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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