Combining radium-223 with abiraterone acetate plus prednisone or prednisolone is not recommended for patients with castration-resistant prostate cancer and bone metastases, ERA 223 researchers report.

The EMA has recommended against the concomitant use of radium-223 dichloride in men who are receiving abiraterone acetate plus prednisone/prednisolone for prostate cancer.

In the radium-223 group, the were no significant declines in the Trails A test, but one (4.8%) of the 21 patients who took the Trails B test and one (5.0%) of the 20 who took the MoCA test experienced a decline of 1.5 SDs or greater.

She explained that following the reports of high fracture rates in the ERA 223 trial of radium-223 plus abiraterone in men with bone-predominant mCRPC, the use of BPA was mandated in the PEACE-3 study, which is evaluating the addition of radium-223 to enzalutamide in a very similar patient population.

The SOC treatment was chosen by the physician but excluded cytotoxic chemotherapy and radium-223.

All men were receiving ADT, either alone or alongside a chemotherapeutic agent (docetaxel or cabazitaxel), an androgen-targeting agent (abiraterone or enzalutamide), or radium-223.

“However, because of the modest response to second-line enzalutamide, other available and appropriate therapies should also be considered for patients progressing after first-line androgen receptor pathway inhibitors, such as taxane chemotherapy and radium-223.”

They also point out that at the time of the phase II trial, docetaxel was the only life-prolonging treatment available, whereas many more, such as cabazitaxel, sipuleucel-T, abiraterone acetate, enzalutamide, and radium-223, had been approved ahead of the phase III trial.

Such outcomes were not collected in the pivotal trial for radium 223, however, and so while anecdotal evidence suggests that it may improve pain more than other agents, it cannot be included on the label.