What question did this study set out to answer?

This research aims to evaluate the impact of 161Tb-PSMA-617 radioligand therapy on health-related quality of life in mCRPC patients.

June 6, 2026Open Access

Health-related Quality of Life in mCRPC Patients Undergoing 161TbTb-PSMA-617 Radioligand Therapy: Pilot Experience From a Real-World Setting

ABArne BlickleUniversitätsklinikum des Saarlandes SGSebastian GanzUniversity of Education Weingarten CBCaroline BurgardUniversitätsklinikum des Saarlandes

Key Points

This research aims to evaluate the impact of 161Tb-PSMA-617 radioligand therapy on health-related quality of life in mCRPC patients.
20 advanced mCRPC patients enrolled in the REALITY registry (NCT04833517)
Patients received a median of two cycles of 161Tb-PSMA-617 RLT with mean activity of 6.1 ± 1.2 GBq per cycle
Health-related quality of life assessed using EORTC QLQ-C30 and adverse events evaluated by CTCAE v5.0.
Patient-reported well-being was largely maintained with stable global health (p = 0.581) and overall quality of life (p > 0.999).
Increased tiredness was noted with statistical significance (p = 0.036).
Most adverse events were mild, with few higher-grade hematological and renal toxicities observed.

Abstract

Abstract Purpose PSMA RLT employing 177 Lu by use of 177 LuLu-PSMA-617 has been demonstrated to be effective and well-tolerated, maintaining or even improving quality of life. Other radionuclides such as 161 Tb are currently under investigation concerning clinical feasibility and therapeutic efficacy. However, patient-centered evaluations of well-being and adverse events are scarce. This study evaluates the impact of 161 TbTb-PSMA-617 RLT on health-related quality of life (HRQoL) across multiple scales, including adverse events. Methods Analysis included 20 advanced, heavily pre-treated mCRPC patients enrolled in the REALITY registry (NCT04833517) who received 161 TbTb-PSMA-617 RLT (median two cycles; mean activity per cycle: 6.1 ± 1.2 GBq) after prior conventional PSMA RLT. HRQoL, covering physical, emotional, cognitive, and social functioning, was assessed using EORTC QLQ-C30. Hematotoxicities, liver and kidney function impairments, as well as xerostomia were evaluated according to CTCAE v5.0. For statistical analysis, the Wilcoxon matched-pairs signed-rank test was employed, with a significance threshold set at p 0.999) remained stable throughout therapy. Most CTCAE ratings were mild or moderate. Worsening under therapy was limited: One anemia case progressed from CTCAE °2 to °4, and another from °2 to °3. Regarding renal function, two cases progressed from °2 to °3. No cases of xerostomia higher than °2 were observed. Conclusion 161 TbTb-PSMA-617 RLT represents a well-tolerated and safe treatment option for advanced mCRPC, with patient-reported quality of life maintained over time, with only rare higher-grade hematological and renal toxicities.

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