At a glance
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A Single-arm Open Label Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Blood Tests, CT scan, and 3 other interventions for Prostate Cancer and 2 related conditions. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The purpose of this study is to look for markers of how Ra-223 improves the lives of men with prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but adds non-standard testing in an attempt to gain insight about how the drug works and how best to track patients who are receiving the drug.
Study Details
Timeline
Interventions
Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.
Standard CT scans will be carried out prior to treatment, week 9, and week 25.
Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.
Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.
Standard bone scans will be carried out prior to treatment, week 9, and week 25.