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

NCT00459654 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-06-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2006-05-31
Completion
2007-05-31

Countries

  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00459654 on ClinicalTrials.gov