Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

Completed

• Conditions: Prostatic Neoplasms, Castration-Resistant
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)

• Registration Number: NCT02803437
• Lead Sponsor: Bayer

Brief Summary

This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

Detailed Description

This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months.

During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. Since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. The physician records patient data as defined in the protocol.

The extended follow-up period is to collect bone fractures and survival with post-treatment information after Xofigo under the real-world in Japan.

The results of this study (except of extended follow-up period) have to be submitted to the Japanese regulatory authorities as a part of the reexamination period (8 years). This study is conducted in accordance with Article 14-4 (re-examination) of the Pharmaceutical Affairs Law, and Good Post-marketing Surveillance Practice from a ministerial ordinance of Ministry of Health, Labor and Welfare in Japan.

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Study Start: 2016-07-21
• Primary Completion: 2022-01-06
• Study Completion: 2024-12-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 334

Inclusion Criteria

• Patients suffered from CRPC with bone metastases
• Patients for whom the decision to initiate treatment with Xofigo is made as per physician's routine clinical practice.
• Xofigo treatment naïve

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Exclusion Criteria

• Patients treated Xofigo previously
• Patients participating in an investigational program with interventions outside of routine clinical practice

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Xofigo / Cohort 1	Radium-223 dichloride (Xofigo, BAY 88-8223)	Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of adverse events as a measure of safety	Up to 6 months	Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
Number of adverse drug reactions as a measure of safety	Up to 6 months	Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system

Secondary Outcome Measures

Name	Time	Method
Change in laboratory findings (e.g. ALP, bone markers)	From Baseline up to 6 month
Change in analgesic use as a surrogate of pain status	From Baseline up to 6 month
Survival rate	Up to 3 years
Post-treatment information	Up to 3 years	Comprises information of post-treatment medication/ therapy for prostate cancer
Number of patients with bone fractures	Up to 3 years