check_circleStudy 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
  • -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
  • - 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
85
Trial Dates
April 2019 - March 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany 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.
    date_rangeTime Frame:
    From baseline to 7 months

Secondary Outcome

  • Change in the total scores of the CTSQ domains
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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

Click here for access to information about Bayer’s transparency standards and Bayer studies.