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

被引：4

作者：

Oprea-Lager, Daniela-Elena ^{[1
]}

Gontier, Eric ^{[2
]}

Garcia-Canamaque, Lina ^{[3
]}

Gauthe, Mathieu ^{[4
]}

Olivier, Pierre ^{[5
]}

Mitjavila, Mercedes ^{[6
]}

Tamayo, Pilar ^{[7
]}

Robin, Philippe ^{[8
,9
]}

Garcia Vicente, Ana Maria ^{[10
]}

Bouyeure, Anne-Charlotte ^{[11
]}

Bailliez, Alban ^{[12
,13
]}

Rodriguez-Fernandez, Antonio ^{[14
,15
]}

Ben Mahmoud, Sinan ^{[16
]}

Vallejo-Casas, Juan Antonio ^{[17
]}

Maksud, Philippe ^{[18
]}

Merlin, Charles ^{[19
,20
]}

Blanc-Durand, Paul ^{[21
,22
]}

Drouet, Clement ^{[23
]}

Tissot, Hubert ^{[24
]}

Vierasu, Irina ^{[25
]}

Vander Borght, Thierry ^{[26
]}

Boos, Evelyne ^{[27
]}

Chossat, Florence ^{[27
]}

Hodolic, Marina ^{[27
]}

Rousseau, Caroline ^{[28
,29
]}

机构：

[1] Univ Amsterdam, VU Univ Med Ctr, Canc Ctr Amsterdam, Dept Radiol & Nucl Med,Med Ctr, Boelelaan 1117, NL-1081 HV Amsterdam, Netherlands

[2] Ctr Cancerol Le Sarthe, Serv Med Nucl, Le Mans, France

[3] Univ CEU San Pablo, Grp HM Hosp, Serv Med Nucl, Madrid, Spain

[4] Hop Tenon, Serv Med Nucl, Paris, France

[5] CHRU, Serv Med Nucl, Nancy, France

[6] Hosp Univ Puerta Hierro Majadahonda, Serv Med Nucl, Madrid, Spain

[7] Hosp Univ Salamanca, Serv Med Nucl, IBSAL, Salamanca, Spain

[8] Ctr Hosp Univ Brest, Serv Med Nucl, Brest, France

[9] Univ Brest, UMR 1304, CHRU Brest, Inserm,GETBO, Brest, France

[10] Hosp Gen Univ Ciudad Real, Serv Med Nucl, Ciudad Real, Spain

[11] Ctr Henri Becquerel, Serv Med Nucl, Rouen, France

[12] Hop St Philibert, Grp Hop Inst Catholique Lille, Serv Med Nucl Humanitep, Lomme Les Lille, France

[13] Hop Prive Le Bois, Serv Med Nucl, Iris Imagerie, Lille, France

[14] Hosp Univ Virgen Nieves, Serv Med Nucl, Granada, Spain

[15] Inst Invest Biosanitaria IBS, Granada, Spain

[16] CHR Metz Thionville, Hop Mercy, Serv Med Nucl, Thionville, France

[17] Hosp Univ Reina Sofia, UGC Med Nucl, Inst Maimonides Invest Biomed Cordoba IMIBIC, Cordoba, Spain

[18] Sorbonne Univ, Hop Pitie Salpetriere, Serv Med Nucl, Paris, France

[19] Ctr Jean Perrin, Serv Med Nucl, Clermont Ferrand, France

[20] Univ Clermont Auvergne, Imagerie Mol & Strategies Theranost, UMR1240, Inserm, Clermont Ferrand, France

[21] CHU H Mondor, Serv Med Nucl, Creteil, France

[22] Univ Paris Est Creteil U PEC, Creteil, France

[23] Ctr Georges Francois Leclerc, Serv Med Nucl, Dijon, France

[24] Inst Curie, Serv Med Nucl, Paris, France

[25] Univ Libre Bruxelles ULB, Dept Nucl Med, HUB, Hop Erasme, Brussels, Belgium

[26] UCLouvain, Serv Med Nucl, CHU UCL Namur, Godinne, Belgium

[27] Curium, Paris, France

[28] Univ Angers, Univ Nantes, INSERM, CNRS,CRCI2NA, Nantes, France

[29] Inst Cancerol Ouest, Serv Med Nucl, St Herblain, France

来源：

EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING | 2023年 / 50卷 / 11期

关键词：

F-18]DCFPyL; Piflufolastat; PYLCLARI; PSMA PET; CT; Biochemical recurrence; Prostate cancer; PSMA PET/CT; RADICAL PROSTATECTOMY; F-18-DCFPYL PET/CT; RECOMMENDATIONS; PROGRESSION; GUIDELINES; CARCINOMA; THERAPY; FAILURE;

D O I：

10.1007/s00259-023-06301-5

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

PurposePrimary objective was to compare the per-patient detection rates (DR) of [F-18]DCFPyL versus [F-18]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).MethodsThis was a prospective, open label, cross-over, comparative study with randomized treatment administration of [F-18]DCFPyL (investigational medicinal product) or [F-18]fluoromethylcholine (comparator). Men with rising prostate-specific antigen (PSA) after initial curative therapy were enrolled. [F-18]DCFPyL and [F-18]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.ResultsA 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 [F-18]DCFPyL- and/or [F-18]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 [F-18]DCFPyL- compared to [F-18]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 & LE; 0.5 ng/ml: 26/74 (35%) vs. 22/74 (30%); PSA 0.5 to & LE; 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 [F-18]DCFPyL- and [F-18]fluoromethylcholine -PET/CT, respectively). [F-18]DCFPyL PET/CT had an impact on PM in 44% (90/204) of patients versus 29% (58/202) for [F-18]fluoromethylcholine. Overall, no drug-related nor serious adverse events were observed.ConclusionsThe primary endpoint of this study was achieved, confirming a significantly higher detection rate for [F-18]DCFPyL compared to [F-18]fluoromethylcholine, in men with first BCR of PCa, across a wide PSA range. [F-18]DCFPyL was safe and well tolerated.

引用

页码：3439 / 3451

页数：13

共 50 条

[1] [18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study
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