NCT00459654

A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer

A Phase II Randomised, Placebo-controlled, Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary objective: To study the biological effectiveness of radium-223 therapy measured as: * Time to occurrence of skeletal-related events(SREs) * Change in bone-specific alkaline phosphatase (bone-ALP) levels Secondary objectives: To study the efficacy of radium-223 therapy in terms of: * Frequency of new SREs * Proportions of patients with an SRE * Proportions of patients with SRE at different time points * Changes of biochemical markers of bone turnover * Treatment response with regard to pain and analgesic use(termed "Palliative effect" in study protocol) * Quality of life assessment * Overall survival To study the safety of the repeated radium-223 regimen Total Enrollment:64 Study start: February 2004

Conditions

• Prostate Cancer
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Radium-223 dichloride (BAY88-8223)	Four Radium-223 injections were given at 4-weekly intervals starting after the first fraction of EBR.
DRUG	Saline	Four Saline injections were given at 4-weekly intervals starting after the first fraction of EBR.

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-05-01
• Completion: 2007-05-01
• First posted: 2007-04-12
• Last updated: 2014-06-25

Locations

3 sites across 2 countries: Sweden, United Kingdom