Table 3.
Ongoing clinical trials
| Trial title | Trial identifier | Trial phase | Patient population | Trial objectives |
|---|---|---|---|---|
| Radium Ra 223 with Enzalutamide Compared to Enzalutamide Alone in Men with Metastatic Castration Refractory Prostate Cancer | NCT02199197 | II | mCRPC | To study 223Ra dichloride with enzalutamide compared to enzalutamide |
| Phase III Radium 223 mCRPC-PEACE III | NCT02194842 | III | mCRPC, asymptomatic or mild symptomatic | To assess whether the upfront combination of enzalutamide and 223Ra improves radiological PFS compared with enzalutamide single agent |
| URANIS – Data Collection in Urological Centers During Treatment with Ra-223 Dichloride (Xofigo) Within the Framework of a Noninterventional Study Assessing OS and Effectiveness Predictors of Ra-223 Dichloride (Xofigo) Treated Chemotherapy-Naive mCRPC Patients in a Real-Life Setting in Germany |
NCT02450812 | IV | mCRPC, chemotherapy-naive, symptomatic bone metastases without known visceral metastases | To assess OS, SSE-free survival, and quality of life |
| Phase II, Open, Nonrandomized Trial Assessing Pain Efficacy with Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer | NCT02278055 | II | mCRPC, symptomatic bone metastases | To determine whether 223Ra is effective in reducing cancer pain within 12 weeks of treatment |
| Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients with Prostate Cancer With Bone Metastases: A Retrospective Database Analysis | NCT02729103 | na | mCRPC | To evaluate treatment patterns, mortality, health care resource utilization, and costs in patients with prostate cancer with bone metastases To evaluate opioids/analgesics |
| Drug Use Investigation of Xofigo, Castration-Resistant Prostate Cancer with Bone Metastases | NCT02803437 | IV | mCRPC | To confirm the clinical usefulness, especially the safety profile, of a drug in the routine clinical practice |
| Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration-Resistant Prostate Cancer (REASSURE) | NCT02141438 | IV | mCRPC | To evaluate the short- and long-term safety profile of 223Ra and to assess the incidence of developing second primary malignancies among patients with prostate cancer who received 223Ra in routine clinical practice settings |
| Phase II Open-Label Study to Evaluate the Efficacy and Safety of Radium in Combination with External Beam Radiotherapy (EBRT) vs EBRT Alone in the Treatment of Castration-Resistant Prostate Carcinoma with Limited Bone Metastases | NCT02484339 | II | mCRPC | To evaluate the efficacy and safety of 223Ra dichloride in combination with EBRT vs EBRT alone |
| uPAR PET/CT in Radium-223-Dichloride Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer | NCT02964988 | II | mCRPC | To investigate 68Ga-NOTA-AE105 positron emission tomography/computed tomography for response evaluation of 223Ra therapy in mCRPC |
| Pain Evaluation in Radium-223-Treated Castration-Resistant Prostate Cancer Patients with Bone Metastases (PARABO) | NCT02398526 | IV | mCRPC | To assess pain- and bone pain-related quality of life in patients with mCRPC who received 223Ra in a real-life nuclear medicine practice setting |
| Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration-Resistant Prostate Cancer (CRPC) | NCT02903160 | II | mCRPC | To determine the clinical benefits of using a rapidly cycling, non-cross-reactive regimen of US Food and Drug Administration-approved prostate cancer therapeutic agents To explore the efficacy of rapidly cycling non-cross-reactive therapies for the treatment of patients with newly diagnosed mCRPC |
| Androgen Deprivation Therapy ± Radium-223 Dichloride in Metastatic Prostate Cancer with Bone Metastases | NCT02582749 | II | Metastatic prostate cancer | To evaluate the safety and efficacy of androgen-deprivation therapy ± 223Ra dichloride in mCRPC To compare the good and bad effects of adding 223Ra dichloride |
| Studies of Prognostic Factors in Castration-Resistant PROState Cancer Treated with Radium-223 (PRORADIUM) | NCT02925702 | IV | mCRPC | To study prognostic factors in patients with mCRPC treated with 223Ra |
| A Phase III Randomized, Double-blind, Placebo-Controlled Trial of Radium-223 Dichloride in Combination with Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-Naive Subjects with Bone Predominant Metastatic Castration-Resistant Prostate Cancer (CRPC) | NCT02043678 | III | mCRPC | To determine whether the addition of 223Ra dichloride to standard treatment can prolong life and delay events specific to prostate cancer that has spread to the bone, such as painful fractures or bone pain that needs to be treated with an X-ray machine |
| A Phase II Study of Radium-223 in Combination with Enzalutamide in Progressive Metastatic Castrate-Resistant Prostate Cancer | NCT02225704 | II | mCRPC | To determine 223Ra safety and tolerability when administered in combination with enzalutamide in progressive mCRPC |
Abbreviations: EBRT, external beam radiotherapy; mCRPC, metastatic castration-resistant prostate cancer; na, not available; OS, overall survival; 233Ra, radium-223; PFS, progression-free survival; SSE, symptomatic skeletal event.