Table 2.
Selected clinical trials using radium-223 in prostate cancer
| Clinical trial design | Title | Status | Primary endpoints | Secondary endpoints |
|---|---|---|---|---|
| NCT02278055 Phase II | Nonrandomized trial assessing pain efficacy with radium-223 in symptomatic mCRPC | Recruiting | Pain response | Decline in alkaline phosphatase and other bone markers |
| NCT02043678Phase III, randomized, double-blind | Radium-223 dichloride and abiraterone acetate compared with placebo and abiraterone acetate for men with cancer of the prostate when medical or surgical castration does not work and when the cancer has spread to the bone, has not been treated with chemotherapy, and is causing no or only mild symptoms (ERA 223) | Recruiting | Symptomatic SRE-free survival | OS, time to opiate use, pain progression, chemotherapy, radiologic PFS, adverse events |
| NCT01934790Phase I/II | Retreatment safety of radium-223 dichloride in castration-resistant prostate cancer with bone metastases | Recruiting | Treatment-related adverse effects, change in blood counts, number of patients who discontinued treatment | Pain improvement, time to pain improvement, radiologic PFS, OS, time to SREs |
| NCT02135484Observation, open-label | Radium 223 in castrate-resistant prostate cancer bone metastases | Recruiting | Markers in predicting OS | |
| NCT02225704Phase II | Radium-223 in combination with enzalutamide | Active, not recruiting | Safety, adverse events | Time to pain, progression, PSA response, OS |
| NCT01810770Phase III | Radium-223 dichloride (Ra-223 Cl2) Asian population study in the treatment of CRPC patients with bone metastasis | Recruiting | OS, adverse events | Change in PSA, time to PSA, progression, SREs |
| NCT02034552Phase II | A randomized phase IIa efficacy and safety study of radium-223 dichloride with abiraterone acetate or enzalutamide in mCRPC | Recruiting | Bone scan response | OS, time to progression |
| NCT02097303Phase II | Open label phase two trial of radium Ra 223 dichloride with concurrent administration of abiraterone acetate plus prednisone in symptomatic castration-resistant (hormone- refractory) prostate cancer subjects with bone metastasis (eRADicAte) | Recruiting | Efficacy | Safety |
| NCT02023697Phase II | Standard dose versus high dose and versus extended standard dose radium-223 dichloride in castration-resistant prostate cancer metastatic to the bone | Recruiting | SRE-free survival | OS, time to radiologic progression, improvement in pain |
| NCT02199197Phase II | Radium Ra 223 with enzalutamide in men with metastatic castration refractory prostate cancer | Recruiting | Level of bone formation markers |
Abbreviations: OS, overall survival; SRE, skeletal-related event; PSA, prostate-specific antigen; PFS, progression-free survival; mCRPC, metastatic castration-resistant prostate cancer.