![]() Consequently, treatment decisions are often based on personal clinical judgment and expert opinion. Īs the treatment landscape for mCRPC continues to change with the emergence of new phase 3 data, there remains a lack of information regarding treatment patterns and outcomes in the real-world setting. ![]() However, findings from the phase 3 ERA 223 trial indicated that concurrent treatment with abiraterone/prednisone and radium-223 did not prolong SSE-free survival but rather led to an increase in the incidence of fractures in uninvolved bone compared with abiraterone/prednisone. Early- or expanded-access programs reported that radium-223 could be safely used in combination with abiraterone/prednisone or enzalutamide in patients with mCRPC. Radium-223 is a targeted alpha therapy that prolonged overall survival (OS) and time to first symptomatic skeletal event (SSE defined as occurrence of new symptomatic pathologic fractures, spinal cord compression, external beam radiation therapy to relieve bone pain, or orthopedic surgical intervention) in patients with mCRPC and bone metastases in the phase 3 ALSYMPCA trial. Because these agents have different mechanisms of action, strategies for combining or sequencing them may provide improved outcomes for select patients however, prospective data supporting the efficacy and safety of these strategies are currently limited. The approval of several agents that prolong survival in patients with metastatic castration-resistant prostate cancer (mCRPC) has provided physicians with the opportunity to select treatment based on patient preference, disease characteristics, accessibility, cost, and clinician experience. Incidence rates for SSEs were reduced when BHAs were used however, BHAs were underutilized. These agents were more commonly given in a layered than a concurrent fashion. In this real-world setting, combination treatments with radium-223 and abiraterone/prednisone or enzalutamide were common. Median OS from mCRPC diagnosis was 28.1 months. ![]() Overall, incidence rates for SSEs and pathologic fractures were 0.35 and 0.11 patients per person-year, respectively. Prior or concomitant bone health agents (BHAs) were received by 67% and 55% of patients, respectively. When these agents were combined, they were often initiated in a layered fashion (73% layered, 23% concurrent). Of the 625 patients treated with radium-223, 22% received it together with abiraterone/prednisone and 27% with enzalutamide. Outcome measures included symptomatic skeletal events (SSEs), overall survival (OS), and patterns of treatments received. The index date was defined as the day of the first radium-223 dose. Treatment with radium-223 plus abiraterone/prednisone or enzalutamide was defined as concurrent if both drugs started within 30 days of one another, or layered when the second drug started ≥30 days after the first. We used the Flatiron Health database to perform a retrospective study of patients with mCRPC treated with radium-223. Previously, the ERA 223 trial (NCT02043678) demonstrated increased fracture risk with concurrent treatment with radium-223 and abiraterone plus prednisone/prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC). ![]() Patients will be treated with radium-223 according to standard of care, while carefully being monitored by obtaining multi-parametric parameters from blood, imaging and tissue.In this study, we evaluated real-world data on radium-223 plus abiraterone/prednisone or enzalutamide. Within the Radium223Insight, 30 patients will be included. The Radium223Insight is a collaborative effort of the Erasmus MC Rotterdam, Radboud UMC Nijmegen and the Franciscus Gasthuis & Vlietland Hospital, Rotterdam. The Radium223Insight study aims to identify biomarkers for early identification of clinical benefit from radium-223 treatment and to better understand immune response during radium-223 treatment in mCRPC patients. In addition, previous studies have shown that radium-223 can induce immune responses, indicating that radium-223 may improve the efficacy of immune checkpoint inhibition. However, as traditional parameters, including PSA, fail in (early) response evaluation, other parameters are needed to guide treatment planning in mCRPC patients, treated with radium-223. Based on the survival results of a randomized phase 3 trial in 2013, the European Medicines Agency (EMA) has approved radium-223 for the treatment of metastatic castration resistant prostate cancer (mCRPC) with bone metastases only.
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