Clinical trial · Observational
Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer
Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation
NCT02141438CI-TRIAL-00096627REASSUREcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Radium-223 dichloride (Xofigo, BAY88-8223)
- description
- Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Primary outcomes (8)
- measure
- Number of Participants With Second Primary Malignancies (SPM)
- timeFrame
- From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223
- description
- Second primary malignancies (SPMs) are defined as new malignancies unrelated to prostate cancer or progression of prostate cancer. All types of SPMs will be collected irrespectively of their relationship to Radium-223. All reported SPMs will be summarized as assessed by the physician
- measure
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
- timeFrame
- From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDO'Sullivan JM, Heinrich D, Castro E, George S, Dizdarevic S, Baldari S, Essler M, Jong IJ, Lastoria S, Hammerer PG, Tombal B, James ND, Meltzer J, Sandstrom P, Sartor O. Alkaline phosphatase decline and pain response as predictors of overall survival benefit in patients treated with radium-223: a post hoc analysis of the REASSURE study. Br J Cancer. 2025 Mar;132(4):354-360. doi: 10.1038/s41416-024-02927-w. Epub 2025 Jan 9. PMID 39789153
- DERIVEDHigano CS, Dizdarevic S, Logue J, Richardson T, George S, de Jong I, Tomaszewski JJ, Saad F, Miller K, Meltzer J, Sandstrom P, Verholen F, Tombal B, Sartor O. Safety and effectiveness of the radium-223-taxane treatment sequence in patients with metastatic castration-resistant prostate cancer in a global observational study (REASSURE). Cancer. 2024 Jun 1;130(11):1930-1939. doi: 10.1002/cncr.35221. Epub 2024 Feb 10. PMID 38340349
- DERIVEDSartor O, Fougere C, Essler M, Ezziddin S, Kramer G, Ellinger J, Nordquist L, Sylvester J, Paganelli G, Peer A, Bogemann M, Meltzer J, Sandstrom P, Verholen F, Song DY. 177Lu-Prostate-Specific Membrane Antigen Ligand After 223Ra Treatment in Men with Bone-Metastatic Castration-Resistant Prostate Cancer: Real-World Clinical Experience. J Nucl Med. 2022 Mar;63(3):410-414. doi: 10.2967/jnumed.121.262240. Epub 2021 Jun 24. PMID 34168015