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Completed

NCT Number: NCT03315260

Treatment Satisfaction With Ra-223 in Japan

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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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations

Multiple Locations, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug

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

Primary outcomes

  1. Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)

    Time frame: 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 outcomes

  1. Change in the total scores of the CTSQ domains

    Time frame: From baseline to 7 months

  2. Change in patient anxiety with prostate cancer using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

    Time frame: From baseline to 7 months

    Changes in the MAX-PC scores will be analyzed as full scores (no sub-domains).

  3. Change in bone-related symptoms using the Functional Assessment of Cancer Therapy Quality of Life Measurement in Patients with Bone Pain (FACT-BP)

    Time frame: From baseline to 7 months

    Change in FACT-BP scores will be analyzed as full scores (no subdomains).

  4. Differences in change in treatment satisfaction (measured by CTSQ) between potential subgroups

    Time frame: From baseline to 7 months

    Potential subgroups will be identified depending on the number of patients available for subgrouping.

  5. Differences in change in prostate cancer anxiety (measured by MAX-PC) between potential subgroups

    Time frame: From baseline to 7 months

    Potential subgroups will be identified depending on the number of patients available for subgrouping.

  6. Differences in change in bone pain (measured by FACT-BP) between potential subgroups

    Time frame: From baseline to 7 months

    Potential subgroups will be identified depending on the number of patients available for subgrouping.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Treatment Satisfaction With Ra-223 Among Japanese Castration Resistant Prostate Cancer (CRPC) Patients

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 20, 2017
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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