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

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 27, 2018

Primary Completion Date

September 30, 2022

Study Completion Date

August 31, 2023

Conditions
Prostate Cancer Metastatic to Bone
Interventions
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)"

Trial Locations (1)

84112

Huntsman Cancer Institute, Salt Lake City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

University of Utah

OTHER