Health-related quality of life, psychological distress, and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 therapy

Background: Radium-223 is a registered treatment for symptomatic bone metastatic castration-resistant prostate cancer (mCRPC). This multicenter, prospective observational cohort study evaluated health-related quality of life (HR-QoL), psychological distress, and fatigue in mCRPC patients treated with radium-223 in routine practice. Methods: Primary endpoint was cancer-specific and bone metastases-related HR-QoL assessed by EORTC QLQ-C30 and BM-22. Secondary endpoints were psychological distress (HADS) and fatigue (CIS-Fatigue). Outcomes were analyzed for the total cohort and by subgroups receiving 1–3 versus 4–5 versus 6 injections. A trajectory analysis explored HR-QoL patterns over time. Results: 122 patients were analyzed. Baseline HR-QoL, pain intensity, psychological distress, and fatigue were worse in patients who did not complete therapy. Completers showed stabilization of HR-QoL with stable psychological distress and fatigue, whereas those who discontinued experienced clinically meaningful and statistically significant deterioration across HR-QoL, psychological distress, and fatigue over time. Trajectory analysis associated HR-QoL deterioration with baseline opioid use, low hemoglobin, and high alkaline phosphatase. Conclusions: Discontinuation of radium-223 was associated with worse baseline and worsening longitudinal HR-QoL, psychological distress, and fatigue versus completion. Patients with baseline opioid use, low hemoglobin, and high ALP warrant specific attention during follow-up to preserve HR-QoL. Clinical trial registration: NCT04995614.