A Study of Stereotactic Body Radiation Therapy and Radium (Ra-223) Dichloride in Prostate Cancer That Has Spread to the Bones

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 12, 2021

Primary Completion Date

November 12, 2027

Study Completion Date

November 12, 2027

Conditions
Prostate Cancer
Interventions
DRUG

Radium dichloride

Two cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks followed 2-3 weeks later by SBRT at a dose of 9 Gy per fraction for 3 fractions (total dose of 27 Gy) to all sites of radiographically apparent metastatic disease. SBRT fractions can be administered every day or every other day per institutional practice. An additional 4 cycles of Radium (Ra-223) dichloride at 55 kBq/kg or 0.00149 mCi/kg or 1.49 uCi/kg every 4 weeks will then be administered, resuming 2-3 weeks after completion of the final fraction of SBRT.

DIAGNOSTIC_TEST

PET Scan

For both arms, the NaF PET will be used to identify discrete osseous lesions which will become index lesions for the study. The simulation scan (either baseline or after 2 cycles of Ra-223) will be used to generate a suitable SBRT radiation plan, per standard practice. If the index lesions are no longer visible after two cycles of Ra-223, we still intend to consolidate the area with radiation. If the lesions are initially radio-occult on the CT and only visible on the NaF PET, we will fuse the pre-treatment NaF PET/CT to the simulation CT after 2 cycles of Ra-223 to delineate the SBRT treatment volumes.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11725

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack

80045

University of Colorado (Data Collection Only), Aurora

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER