Re-treatment Safety of Radium-223 Dichloride in Castration-resistant Prostate Cancer With Bone Metastases
Status:
Completed
Trial end date:
2017-04-12
Target enrollment:
Participant gender:
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.