We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
[<sup>18</sup>F]DCFPyL PET/CT versus [<sup>18</sup>F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study.
- Authors
Oprea-Lager, Daniela-Elena; Gontier, Eric; García-Cañamaque, Lina; Gauthé, Mathieu; Olivier, Pierre; Mitjavila, Mercedes; Tamayo, Pilar; Robin, Philippe; García Vicente, Ana Maria; Bouyeure, Anne-Charlotte; Bailliez, Alban; Rodríguez-Fernández, Antonio; Mahmoud, Sinan Ben; Vallejo-Casas, Juan Antonio; Maksud, Philippe; Merlin, Charles; Blanc-Durand, Paul; Drouet, Clément; Tissot, Hubert; Vierasu, Irina
- Abstract
Purpose: 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). Methods: 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. 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 [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. Conclusions: 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.
- Subjects
ENDORECTAL ultrasonography; POSITRON emission tomography; CANCER relapse; PROSTATE cancer; PROSTATE cancer patients; PROSTATE-specific antigen; RADICAL prostatectomy
- Publication
European Journal of Nuclear Medicine & Molecular Imaging, 2023, Vol 50, Issue 11, p3439
- ISSN
1619-7070
- Publication type
Article
- DOI
10.1007/s00259-023-06301-5