Impact of Baseline Renal Insufficiency on Piflufolastat F-18 Performance and Investigation of Changes in Renal Function Following Piflufolastat F-18 Administration: Results From the OSPREY Trial.

Autor: Chappidi MR; Department of Urology, University of Washington, Seattle, WA. Electronic address: mchappid@uw.edu., Iravani A; Department of Radiology, University of Washington, Seattle, WA., Stambler N; Lantheus, Bedford, MA., Baskaran S; Lantheus, Bedford, MA., DiPippo VA; Lantheus, Bedford, MA., Denes BS; Lantheus, Bedford, MA., Lin DW; Department of Urology, University of Washington, Seattle, WA; Cancer Prevention Program, Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA.
Jazyk: angličtina
Zdroj: Clinical genitourinary cancer [Clin Genitourin Cancer] 2024 Dec; Vol. 22 (6), pp. 102223. Date of Electronic Publication: 2024 Sep 13.
DOI: 10.1016/j.clgc.2024.102223
Abstrakt: Introduction: Piflufolastat F-18, a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical, is predominantly eliminated via urinary excretion, and the kidneys have one of the highest absorbed doses. Therefore, this subgroup analysis aimed to investigate the impact of piflufolastat F-18 on renal function and its diagnostic performance in patients stratified by baseline renal function.
Patients and Methods: The OSPREY clinical trial enrolled 2 cohorts: A-high-risk patients undergoing radical prostatectomy with pelvic lymphadenectomy, and B-patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Baseline estimated glomerular filtration rates were calculated, and patients were stratified by baseline chronic kidney disease (CKD) stage. Changes in serum creatinine within 28 days postdose and diagnostic performance of piflufolastat F-18 were assessed for each CKD stage group in both cohorts.
Results: 385 patients (cohort A, n = 268; cohort B, n = 117) underwent piflufolastat F-18-PET/CT. Baseline and postpiflufolastat F-18 median creatinine levels (mg/dL) were similar for patients in cohort A (0.95 [n = 264] vs. 0.95 [n = 252], respectively) and cohort B (0.93 [n = 116] vs. 0.96 [n = 84], respectively). Among 332 men (cohort A, n = 249; cohort B, n = 83) with baseline and postpiflufolastat creatinine measurements, there were minimal changes in creatinine across all baseline CKD stage groups (median change ranged from -0.02 to 0.023 in groups with >1 patient). The diagnostic performance of piflufolastat F-18 showed no meaningful differences when stratified by baseline CKD stage.
Conclusion: Piflufolastat F-18 appears to be safe and effective for imaging prostate cancer, including men with mild/moderate renal insufficiency.
Competing Interests: Disclosure Research funding was provided by Lantheus. Saradha Baskaran, Nancy Stambler, Vincent A. DiPippo, and Bela S. Denes are full-time employees of Lantheus, and the latter 3 own Lantheus stock.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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