Treatment Satisfaction With Ra-223 in Japan

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

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.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Changes in the MAX-PC scores will be analyzed as full scores (no sub-domains).	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)	Change in FACT-BP scores will be analyzed as full scores (no subdomains).	From baseline to 7 months
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
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Patient reported outcome; Castration resistant prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 19502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No