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

NCT02803437 | Completed

• 1 other identifier: 18212
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

Castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

  Up to 3 years

Study Arms (1)

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)

Interventions

Radium-223 dichloride (Xofigo, BAY 88-8223) DRUG

Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.

Xofigo / Cohort 1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffered from castration resistant prostate cancer with bone metastases

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (4)

• Hosono M, Uemura H, Kakehi Y, Masumori N, Takahashi S, Okayama Y, Sunaya T, Horio T, Kinuya S. [Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age]. Kaku Igaku. 2021;58(1):91-101. doi: 10.18893/kakuigaku.oa.2105. Japanese.

  PMID: 34645727 RESULT

• Uemura H, Masumori N, Takahashi S, Hosono M, Kinuya S, Sunaya T, Horio T, Okayama Y, Kakehi Y. Real-world safety and effectiveness of radium-223 in Japanese patients with castration-resistant prostate cancer (CRPC) and bone metastasis: exploratory analysis, based on the results of post-marketing surveillance, according to prior chemotherapy status and in patients without concomitant use of second-generation androgen-receptor axis-targeted agents. Int J Clin Oncol. 2021 Apr;26(4):753-763. doi: 10.1007/s10147-020-01850-3. Epub 2021 Feb 11.

  PMID: 33575828 RESULT

• Masumori N, Kakehi Y, Hosono M, Kinuya S, Takahashi S, Okayama Y, Sunaya T, Horio T, Uemura H (2020) Post-marketing Surveillance （PMS） Study for Safety and Effectiveness of Radium-223 in Japanese Patients with CRPC and Bone Metastases in Real-world Settings: Exploratory Analysis on Treatment Completion of Six Cycles of Radium-223 and Discontinuation. Medical Consultation & New Remedies 57:705-717

  RESULT

• Takahashi S, Uemura H, Masumori N, Kinuya S, Hosono M, Okayama Y, Sunaya T, Horio T, Kakehi Y (2020) Safety and effectiveness of radium-223 in Japanese patients with CRPC and bone metastases in real world-settings: The results of post-marketing surveillance (PMS). Japanese Journal of Urological Surgery 33(4):435-449

  RESULT

Related 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.

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: July 21, 2016
• Primary Completion: January 6, 2022
• Study Completion: December 18, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

JP (1)