Bertrand Tombal, MD, PhD, highlights real-world data on radium-223 in mCRPC

Data from the global, prospective REASSURE trial (NCT02141438) offer insights into the safety of radium-223 (Xofigo) in a real-world setting. The findings were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany.¹

The study, which included over 1400 patients, assessed outcomes with radium-223 alone (n = 1472) as well as with radium-223 combined with enzalutamide (Xtandi; n = 45). Data showed that the combination of radium-223 plus enzalutamide was generally well-tolerated, with no new safety signals observed.

In an interview with Urology Times®, Bertrand Tombal, MD, PhD, outlined some of the key takeaways from the REASSURE study. Tombal is a professor of urology at the Université Catholique de Louvain (UCL), Cliniques Universitaires Saint-Luc in Brussels, Belgium.

Overall, 73% of patients in the radium-223/enzalutamide arm received all 6 doses of radium-223, compared with 60% in the overall patient population. Serious treatment-emergent adverse events (TEAEs) occurred in 20% of patients in the radium-223 plus enzalutamide arm vs 22% among all patients. Further, drug-related TEAEs occurred in 36% vs 37% of patients, respectively.

Concomitant bone protective agents (denosumab or zoledronic acid) were used in 62% of patients in the combined radium-223/enzalutamide arm vs 41% of patients in the overall patient population. Bone fractures occurred in 7% vs 10% of patients, respectively.

Regarding efficacy, the median overall survival was 19.3 months (95% CI, 12.2 to 26.5) in the radium-223/enzalutamide arm vs 15.6 months (95% CI, 14.6 to 16.4) among the overall patient population.

REFERENCE

1. Jan de Jong I, Sternberg CN, George S, et al. Combined treatment with radium-223 (RAD) and enzalutamide (ENZ) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Insights from the global REASSURE study. Presented at: European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract 2401P. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/2401P.html.pdf