Radium-223 is a registered treatment option for patients with symptomatic bone metastatic castration-resistant prostate cancer (mCRPC). Furthermore, patients’ concerns about the effectivity of systemic therapies can aggravate psychological distress, and thereby negatively influences physical and mental well-being. In addition, androgen deprivation therapy, the standard of care for patients with metastatic prostate cancer, is known to have profound effects on physical and emotional well-being in this population, including fatigue and psychological distress. These complications affect health-related quality of life (HR-QoL), diminish patients’ functional capacities, and lead to decreased overall survival (OS). Clinical trial registration numberīone metastases of prostate cancer may cause considerable pain, impaired mobility, pathological fractures, and spinal cord compression. Specific attention with regard to HR-QoL during follow-up is indicated in patients with opioid use, low hemoglobin and high alkaline phosphatase levels before radium-223 therapy initiation. Patients who discontinued radium-223 therapy showed worse HR-QoL, psychological distress and fatigue at baseline and more frequent deterioration of HR-QoL, psychological distress and fatigue over time when compared to patients who completed therapy. Trajectory analysis revealed that HR-QoL deterioration over time was more likely in patients with baseline opioid use, low hemoglobin and high alkaline phosphatase levels. In patients who completed therapy, stabilization of HR-QoL was perceived and psychological distress and fatigue remained stable, whereas clinically meaningful and statistically significant deterioration of HR-QoL, psychological distress and fatigue over time was observed in patients who discontinued radium-223 therapy. Baseline HR-QoL, pain intensity, psychological distress and fatigue were worse in patients who did not complete radium-223 therapy. In total, 122 patients were included for analysis. A trajectory analysis was performed to explore HR-QoL patterns over time. Outcomes were analyzed for the total cohort and between subgroups (1-3 versus 4-5 versus 6 radium-223 injections). Secondary endpoints were psychological distress and fatigue, evaluated by the HADS and CIS-Fatigue questionnaires. Primary endpoint was cancer-specific and bone metastases-related HR-QoL, as measured by the EORTC QLQ-C30 and BM-22 questionnaires. Aim of this multicenter, prospective observational cohort study was to evaluate health-related quality of life (HR-QoL), psychological distress and fatigue in mCRPC patients treated with radium-223. Radium-223 is a registered treatment option for symptomatic bone metastatic castration-resistant prostate cancer (mCRPC).
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