N/A
Completed N=1,472
Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer
Source: ClinicalTrials.gov NCT02141438 ↗Enrolled (actual)
1,472
Serious AEs
22.1%
Results posted
Sep 2025
Primary outcomePrimary: Number of Participants With Second Primary Malignancies (SPM) — 24 Participants
Summary
Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Second Primary Malignancies (SPM) |
24 | — |
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) |
325 | — |
| PRIMARY Number of Participants With Drug-related Treatment-emergent Adverse Events |
537 | — |
| PRIMARY Number of Participants With Drug-related SAEs |
88 | — |
| PRIMARY Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression |
1133; 339; 1155; 317; 1448; 24 | — |
| PRIMARY Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression |
14.74; 1.77; 15.42 | — |
| PRIMARY Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC) |
398; 49; 1025; 247; 6; 1219 | — |
| PRIMARY Bone Marrow Suppression: Number of Participants Who Underwent Subsequent Chemotherapy That Experienced Febrile Neutropenia or Hemorrhage |
23 | — |
| SECONDARY Overall Survival |
15.6 | — |
| SECONDARY Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire |
3.003; 2.760; 2.464; 2.436; 2.261; 2.262 | — |
| SECONDARY The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire |
3.283; 2.965; 2.656; 2.587; 2.358; 2.495 | — |
| SECONDARY Percentage of Participants With Bone Fractures |
9.7 | — |
| SECONDARY Percentage of Participants With Bone Associated Events |
8.5 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study
- Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
- Signed informed consent
Exclusion Criteria
- Previously treated with Radium-223 for any reason
- Currently treated in clinical trials including other Radium-223 studies
- Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use
Data sourced from ClinicalTrials.gov (NCT02141438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.