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Purpose <p>Evaluating efficacy and safety of individualized [<sup>177</sup>Lu]Lu‑PSMA‑617 radioligand therapy in heavily pretreated post-taxane patients with metastatic castration‑resistant prostate cancer (mCRPC), and to present a comparison with outcomes of non-individualized regimens.</p> Methods <p>Per‑cycle activities of [<sup>177</sup>Lu]Lu-PSMA-617 were individualized by normalizing to body surface area and adjusting for renal clearance, hematopoietic function, and tumor burden and progression parameters. 227 post-taxane mCRPC patients with intense PSMA expression on PET/CT were enrolled in the prospective registry (REALITY; NCT04833517) and retrospectively analyzed. PSA progression-free survival (PSA-PFS) and overall survival (OS) according to Kaplan-Meier analysis, Cox proportional‑hazards models with backward elimination for identification of outcome predictors, safety assessment according to CTCAE v5.0.</p> Results <p>Median administered activity was 7.1 GBq per cycle (range 2.7–11.6 GBq) and cumulative activity 22.3 GBq (range 2.7–77.8 GBq), while patients received a median of 3 cycles within a 6-week interval. After a median follow‑up of 15.9 months (95%CI: 11.2–20.5 months), median PSA‑PFS was 5.1 months (95% CI: 4.0–6.2 months), and median OS 14.5 months (95% CI: 11.4–17.7 months). PSA declined after the first cycle in 63.9% of patients; PSA reduction ≥ 50% occurred in 51.5%. Shortened PSA‑PFS was associated with visceral metastasis (<i>p</i> = 0.001) and ALP ≥ 220 U/L (<i>p</i> = 0.004). Shortened OS was associated with visceral metastasis (<i>p</i> = 0.009), ALP ≥ 220 U/L (<i>p</i> = 0.001), age ≤ 65 years (<i>p</i> = 0.034), hemoglobin &lt; 9&#xa0;g/dL (<i>p</i> = 0.006), and early biochemical progressive disease after 1–2 courses (<i>p</i> &lt; 0.001). Newly occurring or worsening hematologic or renal impairments ≥ CTCAE °3 were uncommon.</p> Conclusion <p>In conclusion, the retrospective real-world analysis suggests that individualized, dose-adapted <sup>177</sup>Lu based PSMA RLT regimens may provide an opportunity to successfully extend applicability of RLT to more challenging clinical scenarios and a broader patient population without compromising safety and survival outcomes.</p>

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Real-world evaluation of [177Lu]Lu-PSMA-617 RLT in post-taxane mCRPC: feasibility and safety of individualized treatment in a challenging cohort

  • 期刊论文

  • 发表日期：

    2026年7月7日

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  • Muammer Misirci,
  • Florian Rosar,
  • Fadi Khreish,
  • Caroline Burgard,
  • Arne Blickle,
  • Mark Bartholomä,
  • Stephan Maus,
  • Moritz B. Bastian,
  • Tilman Speicher,
  • Sven Petto,
  • Sebastian Ganz,
  • Andrea Schaefer-Schuler,
  • Samer Ezziddin

摘要

Purpose

Evaluating efficacy and safety of individualized [177Lu]Lu‑PSMA‑617 radioligand therapy in heavily pretreated post-taxane patients with metastatic castration‑resistant prostate cancer (mCRPC), and to present a comparison with outcomes of non-individualized regimens.

Methods

Per‑cycle activities of [177Lu]Lu-PSMA-617 were individualized by normalizing to body surface area and adjusting for renal clearance, hematopoietic function, and tumor burden and progression parameters. 227 post-taxane mCRPC patients with intense PSMA expression on PET/CT were enrolled in the prospective registry (REALITY; NCT04833517) and retrospectively analyzed. PSA progression-free survival (PSA-PFS) and overall survival (OS) according to Kaplan-Meier analysis, Cox proportional‑hazards models with backward elimination for identification of outcome predictors, safety assessment according to CTCAE v5.0.

Results

Median administered activity was 7.1 GBq per cycle (range 2.7–11.6 GBq) and cumulative activity 22.3 GBq (range 2.7–77.8 GBq), while patients received a median of 3 cycles within a 6-week interval. After a median follow‑up of 15.9 months (95%CI: 11.2–20.5 months), median PSA‑PFS was 5.1 months (95% CI: 4.0–6.2 months), and median OS 14.5 months (95% CI: 11.4–17.7 months). PSA declined after the first cycle in 63.9% of patients; PSA reduction ≥ 50% occurred in 51.5%. Shortened PSA‑PFS was associated with visceral metastasis (p = 0.001) and ALP ≥ 220 U/L (p = 0.004). Shortened OS was associated with visceral metastasis (p = 0.009), ALP ≥ 220 U/L (p = 0.001), age ≤ 65 years (p = 0.034), hemoglobin < 9 g/dL (p = 0.006), and early biochemical progressive disease after 1–2 courses (p < 0.001). Newly occurring or worsening hematologic or renal impairments ≥ CTCAE °3 were uncommon.

Conclusion

In conclusion, the retrospective real-world analysis suggests that individualized, dose-adapted 177Lu based PSMA RLT regimens may provide an opportunity to successfully extend applicability of RLT to more challenging clinical scenarios and a broader patient population without compromising safety and survival outcomes.