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EXCAAPE Trial Published in the European Journal of Cancer

We are pleased to announce that the results for the EXCAAPE trial, sponsored by MEDSIR and funded by Bayer Inc., were published in the European Journal of Cancer. The EXCAAPE trial was a research initiative led by Dr. Joan Carles, the Head of Area at the Oncology Service of Vall d’Hebron Hospital in Barcelona. The study results evaluated Radium-223 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have asymptomatic bone metastases and have progressed on novel hormone therapy. The EXCAAPE added value was to assessing the clinical efficacy of Radium-223 as an alternative to docetaxel in patients with high unmet clinical need.

Prostate cancer continues to be the second most diagnosed cancer worldwide and the fifth leading cause of death in men. Treatment for advanced prostate cancer is androgen deprivation therapy, but most patients will become resistant to this therapy and develop castration resistant prostate cancer. Furthermore, once the cancer spreads, most often to the bones and becomes mCRPC, the five-year survival rate is poor.

Radium-223 is an alpha particle-emitting bone-targeted radionuclide that is currently approved as a treatment for patients with bone symptomatic mCRPC, however there is little data regarding its use for asymptomatic patients. Therefore, the EXCAAPE trial sought to answer this question.

EXCAAPE was a multicenter, single-arm, open-label, phase II trial that recruited 52 patients across nine sites in Spain with mCRPC and asymptomatic bone metastases who have progressed on abiraterone acetate or enzalutamide. The radiographic progression-free survival was 5.5 months, meeting the primary endpoint of the study. Median overall survival as a key secondary endpoint was 14.8 months.

The most common AEs and premature discontinuations were in line with those reported in other studies treating patients with Radium-223.

“Our study demonstrates that for those patients with metastatic castrated resistant prostate cancer with only bone involvement and progressing to first line hormonotherapy. Radium 223 can be an option for those patients who are asymptomatic willing to defer chemotherapy for a more advanced stage.”

-Joan Carles MD PhD

Section Chief | Oncology Service

Director GU, CNS and Sarcoma Program

Vall d’Hebron University Hospital

The results of this trial support Radium-223 as an reasonable option to treat mCRPC patients with asymptomatic bone metastases with Radium-223 after they have progressed on abiraterone acetate or enzalutamide.

We would like to immensely thank the patients and families who kindly participated in this study. Please contact us if you would like more information about the EXCAAPE trial.



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