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Association between PET-based TheraP eligibility and 177Lu-PSMA-617 (LuPSMA) outcomes in VISION-eligible patients with metastatic castration-resistant prostate cancer (mCRPC).

Abstract

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Background: The optimal threshold based on pre-treatment PET for patient selection for LuPSMA is yet to be defined. TheraP trial applied a high threshold for PSMA-expression on PSMA PET and utilized FDG PET to exclude FDG-avid/non-PSMA-avid disease while the VISION trial used only PSMA PET with a lower threshold of PSMA-expression. The stricter criteria in TheraP trial doubled the screening failure rate compared to VISION trial, 28% vs. 12.6%. In this study among VISION-eligible patients, we aimed to compare the outcome of those who were TheraP-Eligible (TheraP-E) to TheraP-Ineligible (TheraP-I). Further, the prognostic value of FDG-PET phenotyping is investigated. Methods: This retrospective cohort study evaluated consecutive VISION-eligible mCRPC patients who received at least one cycle of LuPSMA and had both PSMA- and FDG-PET within one month of each other between June 2022 and January 2023. Patients were blindly classified as TheraP-E vs. TheraP-I. We compared whole-body semiquantitative parameters including total tumor volume (TTV), SUVmean and SUVmax and outcomes including PSA decline of ≥50% relative to baseline (PSA50), PSA-progression-free survival (PSA-PFS), and overall survival (OS) between the groups. Separately, the patients were dichotomized to having dominant FDG-avid disease (uptake > liver in most sites of disease) vs. non-FDG-avid disease and OS were compared by Cox-regression. Results: 46 patients (median age: 72, ECOG 0-2: 89%, visceral disease: 28%) were included with a median follow-up of 10 months (IQR: 8-14). 14/46 (30%) patients assessed as TheraP-I and had lower PSMA-PET SUVmean and SUVmax compared to TheraP-E patients (5.6 vs. 8.8 and 23 vs. 53, p < 0.001 for both) while other PET parameters including PSMA TTV and FDG parameters (SUVmax, SUVmean and TTV) were not statistically different. TheraP-I patients had lower PSA50 response (21% vs. 56%, p = 0.029) but PSA-PFS and OS were not significantly different compared to TheraP-E patients (Table). 37/46 (80%) patients assessed as FDG-avid had an increased risk of death compared to non-FDG-avid counterparts (Table). Conclusions: In a VISION-eligible population receiving LuPSMA, TheraP imaging-based ineligibility was associated with worse PSA response but with no significant difference in PSA-PFS or OS. Clinical investigation of the more permissive VISION inclusion criteria and the importance of FDG-avid disease using a larger sample size is warranted.
Results of Cox-regression models.
CharacteristicNHR95% CIp-value
TheraP-Ineligible (OS)461.20.5, 3.00.7
TheraP-Ineligible (PSA-PFS)402.00.9, 4.30.074
FDG-avid (OS)469.81.3, 74.60.028

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Journal of Clinical Oncology
Pages: 41

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Published online: January 29, 2024
Published in print: February 01, 2024

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Ridvan Arda Demirci
University of Washington, Seattle, WA
Roman Gulati
Fred Hutchinson Cancer Center, Seattle, WA
Alireza Ghodsi
University of Washington, Seattle, WA
Peter Nelson
Fred Hutchinson Cancer Center, Seattle, WA
Heather H. Cheng
Division of Hematology & Oncology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA
Jessica E. Hawley
Fred Hutchinson Cancer Center, Seattle, WA
Todd Yezefski
Division of Hematology & Oncology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA
Michael C. Haffner
Fred Hutchinson Cancer Center, Seattle, WA
Robert Bruce Montgomery
University of Washington, Seattle, WA
Michael Thomas Schweizer
Division of Hematology & Oncology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA
Evan Y. Yu
Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA
Delphine L Chen
Department of Radiology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA
Amir Iravani
Fred Hutchinson Cancer Center, Seattle, WA
University of Washington, Seattle, WA; Fred Hutchinson Cancer Center, Seattle, WA; Division of Hematology & Oncology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA; Department of Radiology, University of Washington & Fred Hutchinson Cancer Center, Seattle, WA

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Ridvan Arda Demirci, Roman Gulati, Alireza Ghodsi, Peter Nelson, Heather H. Cheng, Jessica E. Hawley, Todd Yezefski, Michael C. Haffner, Robert Bruce Montgomery, Michael Thomas Schweizer, Evan Y. Yu, Delphine L Chen, Amir Iravani
Journal of Clinical Oncology 2024 42:4_suppl, 41-41

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