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A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

NCT00699751 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 921

Last updated 2026-02-23

Study results available
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Summary

ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.

Conditions

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.

DRUG

Placebo

Isotonic saline 6 IV administrations separated by 4 weeks intervals.

DRUG

Best standard of care (BSoC)

Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.

Sponsors & Collaborators

Principal Investigators

  • Christopher Parker, MD · The Royal Marsden Hospital, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-12
Primary Completion
2011-07-15
Completion
2014-02-13

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Singapore
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00699751 on ClinicalTrials.gov