Clinical trial NCT02803437: Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
Official title: Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms, Castration-Resistant
Keywords: Castration-resistant prostate cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 334
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffered from 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events as a measure of safety
timeFrame: Up to 6 months
measure: Number of adverse drug reactions as a measure of safety
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in laboratory findings (e.g. ALP, bone markers)
timeFrame: From Baseline up to 6 month
measure: Change in analgesic use as a surrogate of pain status
timeFrame: From Baseline up to 6 month
measure: Number of patients with bone fractures
timeFrame: Up to 3 years
measure: Survival rate
timeFrame: Up to 3 years
measure: Post-treatment information
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: