Trial Condition(s):

Prostatic Neoplasms, Castration-Resistant

Drug use investigation of Xofigo, castration resistant prostate cancer with bone metastases

Bayer Identifier:

18212

ClinicalTrials.gov Identifier:

NCT02803437

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
334
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Japan

Status
Active, not recruiting
 

Trial Design