Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases.

"We would like to acknowledge the contribution of Glenn Flux and George Sgouros for their work on the biodistribution and dosimetry analyses, respectively. We would also like to thank Matt Weitz, of Springer Healthcare Communications, and Anna Battershill (on behalf of Springer Healthcare Communications) for medical writing assistance. This medical writing assistance was funded by Bayer, Japan."

"This open-label, non-randomized, phase I study assessed the PK, biodistribution and radiation dosimetry of a single IV dose of radium-223 when delivered via slow bolus (Trial registration identification: NCT01565746). This was a single center study; eligible patients were recruited from Yokohama City University Hospital in Japan. This study was approved by the Yokohama City University Hospital Institutional Review Board (Chairperson Tomoyuki Saito) and all participants provided signed informed consent. Conclusions: In Japanese patients with CRPC and bone metastases, radium-223 (IV) achieved maximum activity in the bone rapidly and passed through the intestine within 24 h, without signs of activity in other organs. The PK profile and absorbed radiation dose in organs and tissues in Japanese patients were similar to data from non-Japanese patients.: Trial registration identification: NCT01565746."