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A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones

NCT04521361 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-09-19

No results posted yet for this study

Summary

In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).

Conditions

  • Bone Metastatic Castration-resistant Prostate Cancer

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug will be administered as aqueous solution intravenously at a dose of 55 kBq/kg body weight every 4 weeks for 6 cycles (cycle length = 4 weeks).

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2023-10-10
Completion
2025-08-27

Countries

  • Austria
  • France
  • Israel
  • Italy
  • Lithuania
  • United Kingdom

Study Locations

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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 NCT04521361 on ClinicalTrials.gov