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

Prostate Cancer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00459654
• Study type: Interventional
• Source: Bayer
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Completion date: May 2007