drugset / Trial / NCT03304418

Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone

NCT03304418

Phase 2 Completed 20 enrolled University of Utah Bayer · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a phase IIa, open label, single arm, and prospective study of hormone therapy-naïve men with oligometastatic prostate cancer to the bone. The study will test if treating the primary tumor sites and 5 or fewer sites of bone-only metastasis with external beam radiation with concomitant systemic Radium-223 will reduce the utilization of androgen deprivation therapy, improve QOL and improve OS over a the comparator cohort of SWOG intermittent ADT historic cohort.

Timeline

Start
2018-02-27
Primary completion
2022-09-30
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Radium-223 dichloride Other / unclassified 0.055 mbq/kg Intravenous