Prostatic Neoplasms, Castration-Resistant
Conditions
Keywords
Castration-resistant prostate cancer
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 description
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.
Interventions
Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse drug reactions as a measure of safety | 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 events as a measure of safety | Up to 6 months | Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with bone fractures | Up to 3 years | — |
| Change in laboratory findings (e.g. ALP, bone markers) | From Baseline up to 6 month | — |
| Post-treatment information | Up to 3 years | Comprises information of post-treatment medication/ therapy for prostate cancer |
| Survival rate | Up to 3 years | — |
| Change in analgesic use as a surrogate of pain status | From Baseline up to 6 month | — |
Countries
Japan
Outcome results
None listed