[18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study
Daniela E. Oprea‐Lager, É. Gontier, Lina García‐Cañamaque, Mathieu Gauthé, Pierre Olivier, Mercedes Mitjavila, Pilar Tamayo, Philippe Robin, Ana María García Vicente, Anne-Charlotte Bouyeure, Alban Bailliez, Antonio Rodrı́guez-Fernández, Sinan Ben Mahmoud, Juan Antonio Vallejo Casas, Philippe Maksud, C. Merlin, Paul Blanc‐Durand, Clément Drouet, Hubert Tissot, Irina Vierasu, Thierry Vander Borght, Evelyne Boos, Florence Chossat, Marina Hodolič, Caroline Rousseau
Abstract
Abstract 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.