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Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms

NCT02043678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2025-02-19

Study results available
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Summary

To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of NIST update) body weight, intravenous injection (IV-slow bolus), every 4 weeks for 6 cycles

DRUG

Matching placebo (normal saline)

Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles

DRUG

Abiraterone

1000 mg once daily, oral, with best supportive care

DRUG

Prednisone/Prednisolone

5 mg twice daily, oral, with best supportive care

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-30
Primary Completion
2018-02-15
Completion
2024-02-08

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Singapore
  • Spain
  • 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 NCT02043678 on ClinicalTrials.gov