Prostatic Neoplasms
Conditions
Keywords
Castration resistant prostate cancer, Patient reported outcome
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.
Interventions
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)
Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Change in the total scores of the CTSQ domains | From baseline to 7 months | — |
| 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. |
| 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. |
Countries
Japan
Outcome results
None listed