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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostatic Neoplasms, Castration-Resistant
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)

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 Type: Observational
• Enrollment (Actual): 334

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suffered from castration resistant prostate cancer with bone metastases

Description

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

Exclusion Criteria:

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

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
Xofigo / Cohort 1; Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice.	Drug: Radium-223 dichloride (Xofigo, BAY 88-8223); Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of patients with bone fractures		Up to 3 years
Survival rate		Up to 3 years
Post-treatment information	Comprises information of post-treatment medication/ therapy for prostate cancer	Up to 3 years

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2016
• Primary Completion (Actual): January 6, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimated): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: 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; Prostatic Neoplasms, Castration-Resistant; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 18212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No