Primary objective was to compare the per-patient detection rates (DR) of [18F]DCFPyL versus [18F]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).
This was a prospective, open label, cross-over, comparative study with randomized treatment administration of [18F]DCFPyL (investigational medicinal product) or [18F]fluoromethylcholine (comparator). Men with rising prostate-specific antigen (PSA) after initial curative therapy were enrolled. [18F]DCFPyL and [18F]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.
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 [18F]DCFPyL- and/or [18F]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 [18F]DCFPyL- compared to [18F]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 [18F]DCFPyL- and [18F]fluoromethylcholine -PET/CT, respectively). [18F]DCFPyL PET/CT had an impact on PM in 44% (90/204) of patients versus 29% (58/202) for [18F]fluoromethylcholine. Overall, no drug-related nor serious adverse events were observed.
The primary endpoint of this study was achieved, confirming a significantly higher detection rate for [18F]DCFPyL compared to [18F]fluoromethylcholine, in men with first BCR of PCa, across a wide PSA range. [18F]DCFPyL was safe and well tolerated.
European journal of nuclear medicine and molecular imaging. 2023 Jun 21 [Epub ahead of print]
Daniela-Elena Oprea-Lager, Eric Gontier, Lina García-Cañamaque, Mathieu Gauthé, Pierre Olivier, Mercedes Mitjavila, Pilar Tamayo, Philippe Robin, Ana Maria García Vicente, Anne-Charlotte Bouyeure, Alban Bailliez, Antonio Rodríguez-Fernández, Sinan Ben Mahmoud, Juan Antonio Vallejo-Casas, Philippe Maksud, Charles Merlin, Paul Blanc-Durand, Clément Drouet, Hubert Tissot, Irina Vierasu, Thierry Vander Borght, Evelyne Boos, Florence Chossat, Marina Hodolic, Caroline Rousseau
Department of Radiology & Nuclear Medicine, Amsterdam University Medical Centers, VU University Medical Center, Cancer Center Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. ., Service de Médecine Nucléaire, Centre de Cancérologie de La Sarthe, Le Mans, France., Servicio de Medicina Nuclear, Grupo HM Hospitales, Universidad CEU San Pablo, Madrid, Spain., Service de Médecine Nucléaire, Hôpital Tenon, Paris, France., Service de Médecine Nucléaire, CHRU, Nancy, France., Servicio de Medicina Nuclear, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain., Servicio de Medicina Nuclear, IBSAL, Hospital Universitario de Salamanca, Salamanca, Spain., Service de Médecine Nucléaire, Centre Hospitalier Universitaire de Brest, Brest, France., Servicio de Medicina Nuclear, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain., Service de Médecine Nucléaire, Centre Henri Becquerel, Rouen, France., Service de Médecine Nucléaire Humanitep, Groupement Des Hôpitaux de L'Institut Catholique de Lille, Hôpital Saint-Philibert, Lomme, France., Servicio de Medicina Nuclear, Hospital Universitario Virgen de Las Nieves, Granada, Spain., Service de médecine nucléaire, Hôpital de Mercy, CHR Metz-Thionville, Thionville, France., UGC Medicina Nuclear, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Córdoba, Spain., Service de médecine nucléaire Hôpital de la Pitié-Salpétriére, Sorbonne-Université, Paris, France., Service de médecine nucléaire, Centre Jean Perrin, Clermont-Ferrand, France., Service de médecine nucléaire, CHU H. Mondor, Créteil, France; Université Paris Est Créteil (U-PEC), Créteil, France., Service de médecine nucléaire, Centre Georges-François-Leclerc, Dijon, France., Service de médecine nucléaire, Institut Curie, Paris, France., Department of Nuclear Medicine, HUB, Hôpital Erasme Université libre de Bruxelles (ULB), Brussels, Belgium., Service de médecine nucléaire, CHU UCL Namur, UCLouvain, Godinne, Belgium., Curium, Paris, France., Univ Nantes, Univ Angers, INSERM, CNRS, CRCI2NA, Nantes, France.