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Purpose <p>This study investigates the prognostic impact of metastatic disease volume on clinical outcomes in metastatic castration-resistant prostate cancer (mCRPC) patients treated with [¹⁷⁷Lu]Lu-PSMA-617 radioligand therapy ([<sup>177</sup>Lu]Lu-PSMA-617 RLT), aiming to refine patient selection and optimize treatment strategies.</p> Methods <p>This study included 264 mCRPC patients who received a taxane-based therapy and at least one cycle of [<sup>177</sup>Lu]Lu-PSMA-617 RLT at Mayo Clinic between October 2017 and February 2024. Patients were stratified into high-volume (<i>n</i> = 176) or low-volume (<i>n</i> = 88) disease groups per CHAARTED criteria (visceral metastases or ≥ 4 skeletal lesions, with one beyond the vertebral bodies/pelvis). Primary endpoints were overall survival (OS) and PSA response rate (PSA-RR, ≥ 50% PSA decline), with secondary endpoints of PSA progression-free survival (PSA-PFS) and radiographic progression-free survival (rPFS). Statistical differences between the two sub cohorts were assessed using the Mann–Whitney U test. Kaplan–Meier analysis and Cox proportional hazard models assessed survival differences. Univariable and multivariable Cox proportional hazards regression analyses were performed to evaluate prognostic factors. A two-sided p-value &lt; 0.05 was considered statistically significant. All statistical analyses were performed using R statistical software.</p> Results <p>The median age was 71 years in both cohorts. Low-volume patients exhibited superior OS (median 68.1 vs. 27.5 months, <i>p</i> &lt; 0.05) and PSA-RR (71% vs. 55%, <i>p</i> &lt; 0.0001) compared to high-volume patients, with a trend toward improved rPFS (19 vs. 12 months, <i>p</i> = 0.04) and PSA-PFS (21 vs. 13 months, <i>p</i> = 0.01). Multivariable Cox regression analysis identified selected clinical variables as significant prognostic factors for survival outcomes. Baseline PSA, hemoglobin, and alkaline phosphatase levels also differed significantly between groups (<i>p</i> &lt; 0.0001). The median follow-up time was 14.8 months.</p> Conclusion <p>Metastatic disease volume significantly affects [<sup>177</sup>Lu]Lu-PSMA-617 RLT outcomes, with low-volume patients showing better survival and response. While both groups benefited, high-volume patients’ poorer prognosis suggests reduced efficacy, possibly due to tumor heterogeneity or tumor sink effect. Volume-based stratification could optimize therapy, with combination strategies warranting further study to improve high-volume mCRPC outcomes.</p>

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Prognostic Outcomes of [¹⁷⁷Lu]Lu-PSMA-617 radioligand therapy in High-Volume and Low-Volume Metastatic Castration-Resistant Prostate Cancer

  • 期刊论文

  • 发表日期：

    2026年6月23日

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  • Yalda Nikanpour,
  • Geoffrey B. Johnson,
  • Carter A Day,
  • Wael O Zeina,
  • Rimki Haloi,
  • Mindie L Mahon,
  • Lauren A Rhode,
  • Mohamed E Ahmed,
  • Eman E Ahmed,
  • Mahnoor Ashraf,
  • Eugene D Kwon,
  • Jack R Andrews

摘要

Purpose

This study investigates the prognostic impact of metastatic disease volume on clinical outcomes in metastatic castration-resistant prostate cancer (mCRPC) patients treated with [¹⁷⁷Lu]Lu-PSMA-617 radioligand therapy ([177Lu]Lu-PSMA-617 RLT), aiming to refine patient selection and optimize treatment strategies.

Methods

This study included 264 mCRPC patients who received a taxane-based therapy and at least one cycle of [177Lu]Lu-PSMA-617 RLT at Mayo Clinic between October 2017 and February 2024. Patients were stratified into high-volume (n = 176) or low-volume (n = 88) disease groups per CHAARTED criteria (visceral metastases or ≥ 4 skeletal lesions, with one beyond the vertebral bodies/pelvis). Primary endpoints were overall survival (OS) and PSA response rate (PSA-RR, ≥ 50% PSA decline), with secondary endpoints of PSA progression-free survival (PSA-PFS) and radiographic progression-free survival (rPFS). Statistical differences between the two sub cohorts were assessed using the Mann–Whitney U test. Kaplan–Meier analysis and Cox proportional hazard models assessed survival differences. Univariable and multivariable Cox proportional hazards regression analyses were performed to evaluate prognostic factors. A two-sided p-value < 0.05 was considered statistically significant. All statistical analyses were performed using R statistical software.

Results

The median age was 71 years in both cohorts. Low-volume patients exhibited superior OS (median 68.1 vs. 27.5 months, p < 0.05) and PSA-RR (71% vs. 55%, p < 0.0001) compared to high-volume patients, with a trend toward improved rPFS (19 vs. 12 months, p = 0.04) and PSA-PFS (21 vs. 13 months, p = 0.01). Multivariable Cox regression analysis identified selected clinical variables as significant prognostic factors for survival outcomes. Baseline PSA, hemoglobin, and alkaline phosphatase levels also differed significantly between groups (p < 0.0001). The median follow-up time was 14.8 months.

Conclusion

Metastatic disease volume significantly affects [177Lu]Lu-PSMA-617 RLT outcomes, with low-volume patients showing better survival and response. While both groups benefited, high-volume patients’ poorer prognosis suggests reduced efficacy, possibly due to tumor heterogeneity or tumor sink effect. Volume-based stratification could optimize therapy, with combination strategies warranting further study to improve high-volume mCRPC outcomes.