[ 18 F]DCFPyL PET/CT versus [ 18 F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study.

Autor: Oprea-Lager DE; Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, VU University Medical Center, Cancer Center Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. d.oprea-lager@amsterdamumc.nl., Gontier E; Service de Médecine Nucléaire, Centre de Cancérologie de La Sarthe, Le Mans, France., García-Cañamaque L; Servicio de Medicina Nuclear, Grupo HM Hospitales, Universidad CEU San Pablo, Madrid, Spain., Gauthé M; Service de Médecine Nucléaire, Hôpital Tenon, Paris, France., Olivier P; Service de Médecine Nucléaire, CHRU, Nancy, France., Mitjavila M; Servicio de Medicina Nuclear, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain., Tamayo P; Servicio de Medicina Nuclear, IBSAL, Hospital Universitario de Salamanca, Salamanca, Spain., Robin P; Service de Médecine Nucléaire, Centre Hospitalier Universitaire de Brest, Brest, France.; UMR 1304, Inserm, Univ Brest, CHRU Brest, GETBO, Brest, France., García Vicente AM; Servicio de Medicina Nuclear, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain., Bouyeure AC; Service de Médecine Nucléaire, Centre Henri Becquerel, Rouen, France., Bailliez A; Service de Médecine Nucléaire Humanitep, Groupement Des Hôpitaux de L'Institut Catholique de Lille, Hôpital Saint-Philibert, Lomme, France.; Service de Médecine Nucléaire, Hôpital Privé Le Bois, Iris Imagerie, Lille, France., Rodríguez-Fernández A; Servicio de Medicina Nuclear, Hospital Universitario Virgen de Las Nieves, Granada, Spain.; Instituto de Investigación Biosanitaria IBS, Granada, Spain., Mahmoud SB; Service de médecine nucléaire, Hôpital de Mercy, CHR Metz-Thionville, Thionville, France., Vallejo-Casas JA; UGC Medicina Nuclear, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Córdoba, Spain., Maksud P; Service de médecine nucléaire Hôpital de la Pitié-Salpétriére, Sorbonne-Université, Paris, France., Merlin C; Service de médecine nucléaire, Centre Jean Perrin, Clermont-Ferrand, France.; Imagerie moléculaire et stratégies théranostiques, UMR1240, Université Clermont Auvergne, Inserm, Clermont-Ferrand, France., Blanc-Durand P; Service de médecine nucléaire, CHU H. Mondor, Créteil, France; Université Paris Est Créteil (U-PEC), Créteil, France., Drouet C; Service de médecine nucléaire, Centre Georges-François-Leclerc, Dijon, France., Tissot H; Service de médecine nucléaire, Institut Curie, Paris, France., Vierasu I; Department of Nuclear Medicine, HUB, Hôpital Erasme Université libre de Bruxelles (ULB), Brussels, Belgium., Vander Borght T; Service de médecine nucléaire, CHU UCL Namur, UCLouvain, Godinne, Belgium., Boos E; Curium, Paris, France., Chossat F; Curium, Paris, France., Hodolic M; Curium, Paris, France., Rousseau C; Univ Nantes, Univ Angers, INSERM, CNRS, CRCI2NA, Nantes, France.; Service de médecine nucléaire, Institut de cancérologie de l'Ouest, Saint-Herblain, France.
Jazyk: angličtina
Zdroj: European journal of nuclear medicine and molecular imaging [Eur J Nucl Med Mol Imaging] 2023 Sep; Vol. 50 (11), pp. 3439-3451. Date of Electronic Publication: 2023 Jun 21.
DOI: 10.1007/s00259-023-06301-5
Abstrakt: Purpose: Primary objective was to compare the per-patient detection rates (DR) of [ 18 F]DCFPyL versus [ 18 F]fluoromethylcholine positron emission tomography/computed tomography (PET/CT), in patients with first prostate cancer (PCa) biochemical recurrence (BCR). Secondary endpoints included safety and impact on patient management (PM).
Methods: This was a prospective, open label, cross-over, comparative study with randomized treatment administration of [ 18 F]DCFPyL (investigational medicinal product) or [ 18 F]fluoromethylcholine (comparator). Men with rising prostate-specific antigen (PSA) after initial curative therapy were enrolled. [ 18 F]DCFPyL and [ 18 F]fluoromethylcholine PET/CTs were performed within a maximum time interval of 12 days. DR was defined as the percentage of positive PET/CT scans identified by 3 central imaging readers. PM was assessed by comparing the proposed pre-PET/CT treatment with the local treatment", defined after considering both PET/CTs.
Results: A total of 205 patients with first BCR after radical prostatectomy (73%; median PSA = 0.46 ng/ml [CI 0.16;27.0]) or radiation therapy (27%; median PSA = 4.23 ng/ml [CI 1.4;98.6]) underwent [ 18 F]DCFPyL- and/or [ 18 F]fluoromethylcholine -PET/CTs, between July and December 2020, at 22 European sites. 201 patients completed the study. The per-patient DR was significantly higher for [ 18 F]DCFPyL- compared to [ 18 F]fluoromethylcholine -PET/CTs (58% (117/201 patients) vs. 40% (81/201 patients), p < 0.0001). DR increased with higher PSA values for both tracers (PSA ≤ 0.5 ng/ml: 26/74 (35%) vs. 22/74 (30%); PSA 0.5 to ≤ 1.0 ng/ml: 17/31 (55%) vs. 10/31 (32%); PSA 1.01 to < 2.0 ng/ml: 13/19 (68%) vs. 6/19 (32%);PSA > 2.0: 50/57 (88%) vs. 39/57 (68%) for [ 18 F]DCFPyL- and [ 18 F]fluoromethylcholine -PET/CT, respectively). [ 18 F]DCFPyL PET/CT had an impact on PM in 44% (90/204) of patients versus 29% (58/202) for [ 18 F]fluoromethylcholine. Overall, no drug-related nor serious adverse events were observed.
Conclusions: The primary endpoint of this study was achieved, confirming a significantly higher detection rate for [ 18 F]DCFPyL compared to [ 18 F]fluoromethylcholine, in men with first BCR of PCa, across a wide PSA range. [ 18 F]DCFPyL was safe and well tolerated.
(© 2023. The Author(s).)
Databáze: MEDLINE
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