A Phase 2 interventional study of Radium dichloride and PET Scan in Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 7 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
Participants will either receive treatment with standard SBRT and the study drug Radium (Ra-223) dichloride, or standard SBRT alone.
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This study's enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 325 are open to participants now.
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Adequate hematological, liver and renal function
Exclusion Criteria:
adequately treated basal cell or squamous cell skin cancer
Any other serious illness or medical condition, such as but not limited to:
Participants will receive 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 to the target index lesion(s) should be completed within 30 days after simulation after completion of the 2nd infusion of Radium (Ra-223) dichloride. Specific dose constraints, dosing schedules, and management of SBRT to multiple sites will be at the discretion of the treating Radiation oncologist. The goal is to complete simulation and SBRT within 30 days. Only active or progressive disease is to be treated at the discretion of the treating investigator.
Drug: Radium dichloride
Participants will receive 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. SBRT should begin within 30 days (+/- 7 days) of randomization. Only active or progressive disease is to be treated at the discretion of the treating investigator.
Drug: Radium dichloride · Diagnostic Test: PET Scan
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.
Also known as: Ra-223
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.
Also known as: NaF PET
Progression Free Survival
The primary outcome is to compare rates of composite PFS between the two treatment arms using bone scan imaging. A patient will be considered to have disease progression if any of the following events occur from the time of protocol randomization to date of last follow-up: a) PSA biochemical progression OR b) Radiographical progression OR c) clinical progression OR d) start of ADT OR e) death from any cause
Time frame: 1 year
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center