Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program.

ABSTRACT:

Background

Radium-223, a targeted alpha therapy, is used to treat symptomatic patients with castration-resistant prostate cancer (CRPC) and bone metastases. Data for radium-223 in asymptomatic CRPC patients with bone metastases are lacking.

Methods

This was a prospective, single-arm phase 3b study. Patients with metastatic CRPC (malignant lymphadenopathy not exceeding 6 cm was allowed, visceral disease was excluded) received radium-223, 55 kBq/kg intravenously, every 4 weeks for up to 6 cycles. Co-primary endpoints were safety and overall survival. Post hoc analyses were performed according to baseline asymptomatic or symptomatic disease status. Asymptomatic status was defined as no pain and no opioid use at baseline.

Results

Seven hundred eight patients received ≥1 r

SUBMITTER: Heidenreich A 

PROVIDER: S-EPMC6322274 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature