Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer.

ABSTRACT:

Background

Radium-223 dichloride (radium-223) is the first targeted alpha therapy approved for the treatment of castration-resistant prostate cancer (CRPC) with bone metastases. This study investigated the efficacy and safety of radium-223 in Japanese patients with symptomatic CRPC and bone metastases.

Methods

In this open-label, multicenter, phase II study, patients with progressive, symptomatic CRPC and bone metastases were treated with radium-223 (55 kBq/kg, intravenously) in a 4-week cycle for six cycles. The primary endpoint was the percent change in total alkaline phosphatase (ALP) from baseline at 12 weeks. Secondary endpoints included the percent ALP change from baseline to end of treatment (EOT), ALP response rates, percent change in prostate-specific antigen (PSA)

SUBMITTER: Matsubara N 

PROVIDER: S-EPMC5809574 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature