Treatment Satisfaction With Ra-223 in Japan

NCT03315260 | Completed

• 1 other identifier: 19502
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Castration resistant prostate cancer; Patient reported outcome

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 7 months

Secondary Outcomes (6)

• Change in the total scores of the CTSQ domains

  From baseline to 7 months

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

  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)

  From baseline to 7 months

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

  From baseline to 7 months

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

  From baseline to 7 months

Study Arms (1)

Bone metastatic CRPC patients

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

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

Interventions

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)

Bone metastatic CRPC patients

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Japanese CRPC patients designated to receive Ra-223 (Xofigo)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Japan

Location

Related Publications (1)

• Akakura K, Uemura H, Kawakami S, Yokomizo A, Nakamura M, Nishimura K, Komori T, Ledesma DA. Metastatic castration resistant prostate cancer patients' experience with Radium-223 treatment in Japan. Future Oncol. 2024 Apr;20(12):781-798. doi: 10.2217/fon-2023-0870. Epub 2024 Jan 26.

  PMID: 38275149 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 20, 2017
• Study Start: April 11, 2019
• Primary Completion: December 1, 2022
• Study Completion: March 20, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)