Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

Bayer

Status: Completed

Conditions: Prostatic Neoplasms, Castration-Resistant

Treatments: Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)

Study type: Observational

Funder types: Industry

Identifiers

NCT02803437

18212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 334 patients

Sex: Male

Volunteers: No Healthy Volunteers

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 design

334 participants in 1 patient group

Xofigo / Cohort 1

Description:

Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice.

Treatment:

Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)