Comparison of 18F-PSMA-1007 and 18F-Choline PET/CT in prostate cancer patients with biochemical recurrence: a phase 3, prospective, multicenter, randomized study.
Journal
Nuclear medicine communications
ISSN: 1473-5628
Titre abrégé: Nucl Med Commun
Pays: England
ID NLM: 8201017
Informations de publication
Date de publication:
01 Dec 2023
01 Dec 2023
Historique:
medline:
9
11
2023
pubmed:
2
10
2023
entrez:
2
10
2023
Statut:
ppublish
Résumé
This prospective, multicenter, open-label, randomized, crossover trial study was to evaluate the diagnostic performance of 18F-PSMA-1007 (PSMA) vs. 18F-Choline PET/CT (FCH) in prostate cancer (PCa) patients (pts) with biochemical recurrence (BCR). One hundred eighty-six pts, who have undergone primary definitive treatment for PCa with BCR, were recruited to this prospective study. All pts underwent one PSMA and one FCH PET/CT examination in randomized order within a time frame of 8 days and were followed up for at least 6 months (182 ± 10 days). Recurrence of PCa was observed in 176 out of 186 pts. The overall correct detection rate (DR) was 84% (95% CI 0.7967-0.8830) for PSMA and 69% (95% CI 0.6191-0.7489) for FCH, yielding a difference in proportion of 16% ( P < 0.0001). PSMA had a sensitivity of 0.8464 and FCH 0.6857 with an odds ratio of 2.5259 ( P < 0.0001), with statistically significant greater sensitivity of PSMA (ORs, 2.7877 and 2.1283 respectively) ( P < 0.0001). PET/CT imaging led to a more accurate diagnosis in 166 (89.2%) pts, of which PSMA had contributed more than FCH in 91 (54.8%) of them. The DR for cutoff point PSA ≤ 1 ng/ml was higher for PSMA compared to FCH (61.8% vs. 39.5%). DR value of 51.6% for PSMA reached at PSA ≤ 0.3 ng/ml, while FCH reached that DR value with PSA ≤ 2.2 ng/ml. 18F-PSMA-1007 is more efficacious than 18F-Choline for the identification metastatic lesions both in patient and in regional level analysis in PCa patients with BCR.
Identifiants
pubmed: 37779440
doi: 10.1097/MNM.0000000000001770
pii: 00006231-990000000-00214
doi:
Substances chimiques
PSMA-1007
0
Prostate-Specific Antigen
EC 3.4.21.77
fluoromethylcholine
0
Choline
N91BDP6H0X
fluorocholine
6029HGL0QP
Gallium Radioisotopes
0
Types de publication
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1126-1134Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
Références
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2021; 71:209–249.
Schwarzenböck S, Souvatzoglou M, Krause BJ. Choline PET and PET/CT in primary diagnosis and staging of prostate cancer. Theranostics 2012; 2:318–330.
Parsi M, Desai MH, Desai D, Singhal S, Khandwala PM, Potdar RR. PSMA: a game changer in the diagnosis and treatment of advanced prostate cancer. Med Oncol 2021; 38:1–20.
Werner RA, Derlin T, Lapa C, Sheikbahaei S, Higuchi T, Giesel FL, et al. 18F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics 2020; 10:1–16.
Foley RW, Redman SL, Graham RN, Loughborough WW, Little D. Fluorine-18 labelled prostate-specific membrane antigen (PSMA)-1007 positron-emission tomography–computed tomography: normal patterns, pearls, and pitfalls. Clin Radiol 2020; 75:903–913.
Giesel FL, Will L, Lawal I, Lengana T, Kratochwil C, Vorster M, et al. Intraindividual comparison of 18 F-PSMA-1007 and 18 FDCFPyL PET/CT in the prospective evaluation of patients with newly diagnosed prostate carcinoma: a pilot study. J Nucl Med 2018; 59:1076–1080.
Rahbar K, Weckesser M, Ahmadzadehfar H, Schäfers M, Stegger L, Bögemann M. Advantage of 18F-PSMA-1007 over 68Ga-PSMA-11 PET imaging for differentiation of local recurrence vs. urinary tracer excretion. Eur J Nucl Med Mol Imaging 2018; 45:1076–1077.
Pattison DA, Debowski M, Gulhane B, Arnfield EG, Pelecanos AM, Garcia PL, et al. Prospective intra-individual blinded comparison of [18F]PSMA-1007 and [68 Ga]Ga-PSMA-11 PET/CT imaging in patients with confirmed prostate cancer. Eur J Nucl Med Mol Imaging 2021; 49:789–789.
Rahbar K, Afshar-Oromieh A, Bögemann M, Wagner S, Schäfers M, Stegger L, et al. 18F-PSMA-1007 PET/CT at 60 and 120 minutes in patients with prostate cancer: biodistribution, tumour detection and activity kinetics. Eur J Nucl Med Mol Imaging 2018; 45:1329–1334.
Treglia G, Annunziata S, Pizzuto DA, Giovanella L, Prior JO, Ceriani L. Detection rate of 18F-labeled PSMA PET/CT in biochemical recurrent prostate cancer: a systematic review and a meta-analysis. Cancers 2019; 11:710.
Huang Y-T, Tseng N-C, Chen Y-K, Huang K-H, Lin H-Y, Huang Y-Y, et al. The detection performance of 18F–prostate-specific membrane antigen-1007 PET/CT in primary prostate cancer: a systemic review and meta-analysis. Clin Nucl Med 2022; 47:755–762.
Commissioner O of the (2020) FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targeted-pet-imaging-drug-men-prostate-cancer . [Accessed 6 August 2022]
Alberts IL, Seide SE, Mingels C, Bohn KP, Shi K, Zacho HD, et al. Comparing the diagnostic performance of radiotracers in recurrent prostate cancer: a systematic review and network meta-analysis. Eur J Nucl Med Mol Imaging 2021; 48:2978–2989.
de Groot EH, Post N, Boellaard R, Wagenaar NR, Willemsen AT, van Dalen JA. Optimized dose regimen for whole-body FDG-PET imaging. EJNMMI Res 2013; 3:63.
Prostate TP (2007) The palpable prostate: PSA doubling time - R Code. Palpable Prostate. http://palpable-prostate.blogspot.com/2007/02/psa-doubling-time-r-code.html . [Accessed 2 August 2022]
(2008) PSA velocity: is it important to prostate cancer risk. NEW PROSTATE CANCER INFOLINK. https://prostatecancerinfolink.net/diagnosis/psa-testing/psa-velocity/ . [Accessed 2 August 2022]
Ferrari M, Treglia G. (2021) 18F-PSMA-1007 PET in biochemical recurrent prostate cancer: an updated meta-analysis. Contrast Media Mol Imaging 2021; 2021:1–12.
Ahmadi Bidakhvidi N, Laenen A, Jentjens S, Deroose CM, Van Laere K, De Wever L, et al. Parameters predicting [18F]PSMA-1007 scan positivity and type and number of detected lesions in patients with biochemical recurrence of prostate cancer. EJNMMI Res 2021; 11:41.
Morawitz J, Kirchner J, Lakes J, Bruckmann NM, Mamlins E, Hiester A, et al. PSMA PET/CT vs. CT alone in newly diagnosed biochemical recurrence of prostate cancer after radical prostatectomy: comparison of detection rates and therapeutic implications. Eur J Radiol 2021; 136:109556.
Dietlein F, Kobe C, Hohberg M, Zlatopolskiy BD, Krapf P, Endepols H, et al. Intraindividual comparison of 18F-PSMA-1007 with renally excreted PSMA ligands for PSMA PET imaging in patients with relapsed prostate cancer. J Nucl Med 2020; 61:729–734.
Giesel FL, Will L, Kesch C, Freitag M, Kremer C, Merkle J, et al. Biochemical recurrence of prostate cancer: initial results with [18F]PSMA-1007 PET/CT. J Nucl Med 2018; 59:632–635.
Giesel FL, Knorr K, Spohn F, Will L, Maurer T, Flechsig P, et al. Detection efficacy of 18F-PSMA-1007 PET/CT in 251 patients with biochemical recurrence of prostate cancer after radical prostatectomy. J Nucl Med 2019; 60:362–368.
Liu A, Zhang M, Huang H, Zhang C, Ruan X, Lin W, et al. Clinical utility of 18F-PSMA-1007 positron emission tomography/magnetic resonance imaging in prostate cancer: a single-center experience. Front Oncol 2021; 10:612701.
Rahbar K, Afshar-Oromieh A, Seifert R, Wagner S, Schäfers M, Bögemann M, et al. Diagnostic performance of 18F-PSMA-1007 PET/CT in patients with biochemical recurrent prostate cancer. Eur J Nucl Med Mol Imaging 2018; 45:2055–2061.
Rauscher I, Krönke M, König M, Gafita A, Maurer T, Horn T, et al. Matched-pair comparison of 68Ga-PSMA-11 PET/CT and 18F-PSMA-1007 PET/CT: frequency of pitfalls and detection efficacy in biochemical recurrence after radical prostatectomy. J Nucl Med 2020; 61:51–57.
Sachpekidis C, Afshar-Oromieh A, Kopka K, Strauss DS, Pan L, Haberkorn U, et al. 18F-PSMA-1007 multiparametric, dynamic PET/CT in biochemical relapse and progression of prostate cancer. Eur J Nucl Med Mol Imaging 2020; 47:592–602.
Sprute K, Kramer V, Koerber SA, Meneses M, Fernandez R, Soza-Ried C, et al. Diagnostic accuracy of 18F-PSMA-1007 PET/CT imaging for lymph node staging of prostate carcinoma in primary and biochemical recurrence. J Nucl Med 2021; 62:208–213.
Watabe T, Uemura M, Soeda F, Naka S, Ujike T, Hatano K, et al. High detection rate in [18F]PSMA-1007 PET: interim results focusing on biochemical recurrence in prostate cancer patients. Ann Nucl Med 2021; 35:523–528.
Witkowska-Patena E, Giżewska A, Dziuk M, Miśko J, Budzyńska A, Walęcka-Mazur A. Head-to-head comparison of 18F-prostate-specific membrane antigen-1007 and 18F-fluorocholine PET/CT in biochemically relapsed prostate cancer. Clin Nucl Med 2019; 44:e629–e633.
Witkowska-Patena E, Giżewska A, Dziuk M, Miśko J, Budzyńska A, Walęcka-Mazur A. Diagnostic performance of 18F-PSMA-1007 PET/CT in biochemically relapsed patients with prostate cancer with PSA levels ≤ 2.0 ng/ml. Prostate Cancer Prostatic Dis 2020; 23:343–348.
Wondergem M, van der Zant FM, Broos WAM, Knol RJJ. Matched-pair comparison of 18F-DCFPyL PET/CT and 18F-PSMA-1007 PET/CT in 240 prostate cancer patients: interreader agreement and lesion detection rate of suspected lesions. J Nucl Med 2021; 62:1422–1429.
Wang R, Shen G, Huang M, Tian R. The diagnostic role of 18F-choline, 18F-fluciclovine and 18F-PSMA PET/CT in the detection of prostate cancer with biochemical recurrence: a meta-analysis. Front Oncol 2021; 11:684629.
Ettala O, Malaspina S, Tuokkola T, Luoto P, Löyttyniemi E, Boström PJ, et al. Prospective study on the effect of short-term androgen deprivation therapy on PSMA uptake evaluated with 68Ga-PSMA-11 PET/MRI in men with treatment-naïve prostate cancer. Eur J Nucl Med Mol Imaging 2020; 47:665–673.
Conteduca V, Poti G, Caroli P, Russi S, Brighi N, Lolli C, et al. Flare phenomenon in prostate cancer: recent evidence on new drugs and next generation imaging. Ther Adv Med Oncol 2021; 13:1758835920987654.
Panagiotidis E, Paschali A, Giannoula E, Chatzipavlidou V. Rib fractures mimicking bone metastases in 18F-PSMA-1007 PET/CT for prostate cancer. Clin Nucl Med 2019; 44:e46–e48.
Awenat S, Piccardo A, Carvoeiras P, Signore G, Giovanella L, Prior JO, et al. Diagnostic role of 18F-PSMA-1007 PET/CT in prostate cancer staging: a systematic review. Diagn Basel Switz 2021; 11:552.
Arnfield EG, Thomas PA, Roberts MJ, Pelecanos AM, Ramsay SC, Lin CY, et al. Clinical insignificance of [18F]PSMA-1007 avid non-specific bone lesions: a retrospective evaluation. Eur J Nucl Med Mol Imaging 2021; 48:4495–4507.
Roland A, Drouet C, Boulahdour H, Cochet A, De Bari B. Unusual uptakes on 18F-fluorocholine positron emission tomography/computed tomography (PET/CT): a retrospective study of 368 prostate cancer patients referred for a biochemical recurrence or an initial staging. Quant Imaging Med Surg 2021; 11:172–182.
Panagiotidis E, Paschali A, Xourgia X, Chatzipavlidou V. False-positive 18F-PSMA-1007 and true-negative 18F-fluorocholine PET/CT splenic hemangioma. Clin Nucl Med 2020; 45:960–961.
Treglia G, Pereira Mestre R, Ferrari M, Bosetti DG, Pascale M, Oikonomou E, et al. Radiolabelled choline versus PSMA PET/CT in prostate cancer restaging: a meta-analysis. Am J Nucl Med Mol Imaging 2019; 9:127–139.
De Man K, Van Laeken N, Schelfhout V, et al. 18F-PSMA-11 versus 68Ga-PSMA-11 positron emission tomography/computed tomography for staging and biochemical recurrence of prostate cancer: a prospective double-blind randomised cross-over trial. Eur Urol 2022. doi:10.1016/j.eururo.2022.05.010.
doi: 10.1016/j.eururo.2022.05.010
Paymani Z, Rohringer T, Vali R, Loidl W, Alemohammad N, Geinitz H, et al. Diagnostic performance of [18F]Fluorocholine and [68Ga]Ga-PSMA PET/CT in prostate cancer: a comparative study. J Clin Med 2020; 9:2308.
Cerci JJ, Fanti S, Lobato EE, Kunikowska J, Alonso O, Medina S, et al. Diagnostic performance and clinical impact of 68Ga-PSMA-11 PET/CT imaging in early relapsed prostate cancer after radical therapy: a prospective multicenter study (IAEA-PSMA Study). J Nucl Med 2022; 63:240–247.