Treatment Satisfaction With Ra-223 in Japan

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315260
• Other study ID #: 19502
• Status: Completed
• Start date: April 11, 2019
• Est. completion date: March 20, 2023

Study information

• Verified date: February 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 20, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)

Locations

Country	Name	City	State
Japan	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

References & 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 Jan 26. doi: 10.2217/fon-2023-0870. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the total scores of the CTSQ domains		From baseline to 7 months
Secondary	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).	From baseline to 7 months
Secondary	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).	From baseline to 7 months
Secondary	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.	From baseline to 7 months
Secondary	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.	From baseline to 7 months
Secondary	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.	From baseline to 7 months

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