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:
EudraCT Number:
Not Available
EU CT 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
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
| Locations | |
|---|---|
Locations Investigative Site Many locations, Japan | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Drug use investigation of Xofigo, castration resistant prostate cancer with bone metastases
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of adverse events as a measure of safetyEvents will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding systemTimeframe: Up to 6 months
- Number of adverse drug reactions as a measure of safetyEvents will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding systemTimeframe: Up to 6 months
Secondary Outcome
- Change in laboratory findings (e.g. ALP, bone markers)Timeframe: From Baseline up to 6 month
- Change in analgesic use as a surrogate of pain statusTimeframe: From Baseline up to 6 month
- Number of patients with bone fracturesTimeframe: Up to 3 years
- Survival rateTimeframe: Up to 3 years
- Post-treatment informationComprises information of post-treatment medication/ therapy for prostate cancerTimeframe: Up to 3 years
Additional Information
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