Treatment Satisfaction With Ra-223 in Japan

Bayer

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study type: Observational

Funder types: Industry

Identifiers

NCT03315260

19502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 design

85 participants in 1 patient group

Bone metastatic CRPC patients

Description:

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

Treatment:

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)