BAY88-8223, Dose Finding Study in Patients With HRPC

Phase 2 Completed 122 enrolled Bayer

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.

Timeline

Start: 2006-05
Primary completion: 2008-12
Completion: 2009-12

Outcome

Met primary endpoint

paper The study met its primary end point with a statistically significant dose-response relationship in confirmed ≥ 50% PSA declines PMID 23000088 ↗

paper five patients (13%) in the 80-kBq/kg dose group (p=0.0297). PMID 23000088 ↗

Publications

Results Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germa JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Radium-223 dichloride	Other / unclassified	0.025 mbq/kg	Other
Subject	Radium-223 dichloride	Other / unclassified	0.05 mbq/kg	Other
Subject	Radium-223 dichloride	Other / unclassified	0.08 mbq/kg	Other