NCT03304418

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

A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer Metastatic to Bone

Interventions

Type	Name	Description
DRUG	Radium Ra 223 Dichloride	Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
RADIATION	Radiation	All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation. Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2: * Single fraction: 16 Gy total at 16 Gy per fraction (SBRT) * Three fractions: 24 Gy total at 8 Gy per fraction (SBRT) * Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator. * Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)

Timeline

• Start date: 2018-02-27
• Primary completion: 2022-09-30
• Completion: 2023-08-31
• First posted: 2017-10-09
• Last updated: 2025-04-30
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study