Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
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|ClinicalTrials.gov Identifier: NCT02803437|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment|
|Prostatic Neoplasms, Castration-Resistant||Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)|
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 [Patient Registry]|
|Actual Enrollment :||334 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases|
|Actual Study Start Date :||July 21, 2016|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||May 31, 2021|
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.
- 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
- 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 ]
- Number of patients with bone fractures [ Time Frame: Up to 3 years ]
- Survival rate [ Time Frame: Up to 3 years ]
- Post-treatment information [ Time Frame: Up to 3 years ]Comprises information of post-treatment medication/ therapy for prostate cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803437
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|