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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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, 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 outcome variables for the primary objective are Treatment Emergent Adverse Event (TEAEs) and Adverse Drug Reaction (ADRs). The outcome variables for secondary objectives include laboratory findings (e.g. Alkaline Phosphatase [ALP], bone markers if measured) and pain status (analgesic utility).

The results of this study have to be submitted to the Japanese regulatory authorities as a part of the re-examination package after the completion of the re-examination 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.

Sponsor: Bayer

Current Primary Outcome:

• Number of adverse events as a measure of safety [ Time Frame: 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 [ Time Frame: Up to 6 months ]
  Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in laboratory findings (e.g. ALP, bone markers) [ Time Frame: From Baseline up to 6 month ]
• Change in Analgesic use as a surrogate of pain status [ Time Frame: From Baseline up to 6 month ]

Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: June 14, 2016
Date Started: July 21, 2016
Date Completion: December 31, 2018
Last Updated: May 9, 2017
Last Verified: May 2017