Background/Objectives: To conduct a systematic review to evaluate the detection rates (DR) of the three FDA-approved PSMA-targeted radiopharmaceuticals in patients with recurrent prostate cancer. Methods: Two individuals systematically searched MEDLINE, ScienceDirect, and Cochrane Libraries (February 2025), and independently reviewed all results to identify studies reporting patient-level 68Ga-PSMA-11, 18F-DCFPyL, or 18F-flotufolastat DR in ≥100 evaluable patients with recurrent prostate cancer. Sample-weighted means (SWM) of extracted DR were calculated. Results: Of 5059 published articles, 37 met our inclusion criteria, reporting data from 8843 patients undergoing 68Ga-PSMA-11 (n = 27), 18F-DCFPyL (n = 8), or 18F-flotufolastat (n = 2) studies. Heterogeneity was noted across enrolled populations, particularly in prior treatments. 68Ga-PSMA-11 studies recruited patients with marginally higher median PSA than 18F-DCFPyL or 18F-flotufolastat studies (median PSA ranged from 0.1 to 10.7, 0.2-2.5, and 0.6-1.1, respectively). Reported overall DR ranged from 25 to 91% for 68Ga-PSMA-11, 49-86% for 18F-DCFPyL, and 73-83% for 18F-flotufolastat, with SWM of 71%, 66%, and 79%, respectively. Post-prostatectomy DR were reported in 18 articles, resulting in SWM DR of 58% for 68Ga-PSMA-11 (n = 12), 55% for 18F-DCFPyL (n = 4), and 76% for 18F-flotufolastat (n = 2). Among post-radiotherapy patients, SWM were 87% for 68Ga-PSMA-11 (n = 4), 90% for 18F-DCFPyL (n = 2), and 99% for 18F-flotufolastat (n = 1). SWM DR at PSA < 1 ng/mL were 53%, 42%, and 66% for 68Ga-PSMA-11 (n = 13), 18F-DCFPyL (n = 5), and 18F-flotufolastat (n = 2), respectively. Conclusions: Considerable heterogeneity exists across populations in studies of diagnostic PET radiopharmaceuticals. Despite a paucity of 18F-DCFPyL and 18F-flotufolastat studies compared with 68Ga-PSMA-11, the available data suggest that all three radiopharmaceuticals provide high overall DR in patients with biochemical recurrence of prostate cancer.
Diagnostics (Basel, Switzerland). 2025 May 13*** epublish ***
Soroush Rais-Bahrami, Phillip Davis, Albert Chau, Samuel J Galgano, Brian F Chapin, David M Schuster, Catriona M Turnbull
Department of Urology, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Blue Earth Diagnostics Inc., Needham, MA 02494, USA., Blue Earth Diagnostics Ltd., Oxford OX4 4GA, UK., Department of Radiology, University of Alabama at Birmingham, Birmingham, AL 35294, USA., Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA., Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, GA 30322, USA.