NCT01934790

Re-treatment Safety of Radium-223 Dichloride in Castration-resistant Prostate Cancer With Bone Metastases

A Re-treatment Safety Study of Radium-223 Dichloride in Subjects With Castration-resistant Prostate Cancer With Bone Metastases Who Received an Initial Course of Six Doses of Radium-223 Dichloride 50 kBq/kg Every Four Weeks

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dichloride that led to the discontinuation of treatment. 40 Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg IV every 4 weeks. The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit every 4 weeks, prior to receiving radium-223 dichloride. After the end of treatment visit the subjects will enter the active follow up period. Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride. After the 2 years of active follow-up, subjects will enter the long-term follow-up period and will be followed via telephone follow-up at 6-month intervals for late toxicities and survival up to 7 years after the last dose of radium-223 dichloride or until death. Joint safety reviews will regularly take place to oversee safety of the subjects conducted at regular intervals. An interim analysis of the safety data will be conducted during the study.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Radium-223 dichloride (Xofigo, BAY88-8223)	Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.

Timeline

• Start date: 2013-12-22
• Primary completion: 2015-06-04
• Completion: 2017-04-12
• First posted: 2013-09-04
• Last updated: 2018-03-26
• Results posted: 2016-09-29

Locations

16 sites across 7 countries: United States, Finland, Israel, Italy, Norway, Spain, Sweden

Regulatory

• FDA-regulated drug study