18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard

•18F-fluciclovine PET has high sensitivity, but low specificity for localization of known primary prostate cancer.•18F-fluciclovine PET has high specificity, but low sensitivity for detection of primary lymph node metastases.•Few 18F-fluciclovine studies have systematic sector-based histopathology that allows calculation of sensitivity and specificity. •18F-fluciclovine PET has high sensitivity, but low specificity for localization of known primary prostate cancer.•18F-fluciclovine PET has high specificity, but low sensitivity for detection of primary lymph node metastases.•Few 18F-fluciclovine studies have systematic sector-based histopathology that allows calculation of sensitivity and specificity. Prostate cancer is the most common cancer in men, and has the second-highest mortality among male malignant carcinomas.1Bray F. Ferlay J. Soerjomataram I. et al.Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.CA Cancer J Clin. 2018; 68: 394-424Crossref PubMed Scopus (37791) Google Scholar At initial diagnosis, the extent and spread of the cancer are key factors in deciding the appropriate treatment. For localized disease, the main treatment modalities are radical prostatectomy, external beam radiotherapy, or brachytherapy. About one-third of patients develop recurrence after primary definitive treatment.2Kishan A.U. Chu F.I. King C.R. et al.Local failure and survival after definitive radiotherapy for aggressive prostate cancer: an individual patient-level meta-analysis of six randomized trials.Eur Urol. 2020; 77: 201-208Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar Localization of recurrent disease is critical to the subsequent therapeutic strategy and prognosis because focal salvage treatment options are emerging.3Duijzentkunst D.A. Peters M. van der Voort van Zyp J.R. et al.Focal salvage therapy for local prostate cancer recurrences after primary radiotherapy: a comprehensive review.World J Urol. 2016; 34: 1521-1531Crossref PubMed Scopus (48) Google Scholar,4Zdrojowy R. Dembowski J. Malkievwicz B. et al.Salvage local therapy for radiation-recurrent prostate cancer - where are we?.Cent Eur J Urol. 2016; 69: 264-270PubMed Google Scholar In the past, the role of PET for prostate cancer imaging has been limited. However, in recent years, several new PET tracers have emerged that offer improved diagnostic performance for detecting localized disease and metastases at initial diagnosis and localize disease recurrence.5Walker S.M. Lim I. Lindenberg L. et al.Positron emission tomography (PET) radiotracers for prostate cancer imaging.Abdom Radiol. 2020; 45: 2165-2175Crossref PubMed Scopus (9) Google Scholar One of these PET tracers is trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid (anti-18F-FACBC, 18F-fluciclovine). 18F-fluciclovine is a radiolabeled amino acid analogue that exploits the increased demand of amino acids in tumor tissue for prostate cancer imaging6Schuster D.M. Votaw J.R. Nieh P.T. et al.Initial experience with the radiotracer anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid with PET/CT in prostate carcinoma.J Nucl Med. 2007; 48: 56-63PubMed Google Scholar (Fig. 1). Long half-life and limited urinary excretion are also desirable features of 18F-fluciclovine.7Asano Y. Inoue Y. Ikeda Y. et al.Phase I clinical study of NMK36: a new PET tracer with the synthetic amino acid analogue anti-[18F]FACBC.Ann Nucl Med. 2011; 25: 414-418Crossref PubMed Scopus (30) Google Scholar At present, 18F-fluciclovine is approved in the United States for specific indications: suspected prostate cancer recurrence based on increased prostate-specific antigen (PSA) level.8US Food and Drug Administration FDA Approves new diagnostic imaging agent to detect recurrent prostate cancer.https://fda.gov/news-events/press-announcements/fda-approves-new-diagnostic -imaging-agent-detect-recurrent-prostate-cancerGoogle Scholar This article summarizes studies of diagnostic accuracy of 18F-fluciclovine PET for assessment of patients with prostate cancer with systematic sector-based histopathology as reference standard. The systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.9Moher D. Liberati A. Tetzlaff J. et al.Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.PLoS Med. 2009; 6: e1000097Crossref PubMed Scopus (34498) Google Scholar An information specialist (H.S.) planned and performed the systematic literature searches in MEDLINE (Ovid), Embase (Ovid), Cochrane Database of Systematic Reviews (Wiley), Cochrane Central Register of Controlled Trials, including references from ClinicalTrials.gov and The World Health Organization (WHO) International Clinical Trials Registry Platform (Wiley) and Scopus (Elsevier). Search terms were discussed in detail with 2 of the reviewers (A.J.T., T.S.) and the authors searched for a combination of subject headings, where applicable, and text words, including synonyms, for “fluciclovine f 18 AND prostate cancer.” The following strategy was used in MEDLINE (Ovid) and adapted to the other databases: “(((((fluciclovine or fluorocyclobutane∗ or FACBC) adj3 (F-18 or 18F)) or ge-148 or ge148 or F-FACBC or axumin or NMK-36 or NMK36 or NMK-36c or "1-amino-3-fluorocyclobutane-1-carboxylic acid").mp.) OR ((exp Prostatic Neoplasms/or (prostat∗ adj3 (neoplasm∗ or cancer∗ or tumo?r∗ or carcinom∗)).mp.) and FACBC.mp.)).” Filters to exclude animal studies were applied in MEDLINE and Embase. All searches were performed on July 14 2020. The complete search strategy for all databases can be obtained from the corresponding author. The results from all searches were imported into EndNote and duplicates were removed. The remaining references were imported in the Rayyan screening software.10Ouzzani M. Hammady H. Fedorowicz Z. et al.Rayyan – a web and mobile app for systematic reviews.Syst Rev. 2016; 5: 210Crossref PubMed Scopus (2600) Google Scholar The PICO (patient, intervention, comparator, outcome) framework was used to define the eligibility criteria: the study must consist of patients with prostate cancer (P), the patients must have had 18F-fluciclovine PET (I), the comparator must be systematic sector-based histopathology (C), and the outcome must be diagnostic performance given as sensitivity and specificity (O). Furthermore, the study must report sector-based data either as individual data or as summary diagnostic accuracy and contain at least 10 patients fulfilling all these criteria. 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Scopus Google F. et of and in detection of recurrent prostate cancer in J Radiol. 2018; Full Text Full Text PDF PubMed Scopus (22) Google Nieh P.T. et experience of the detection and diagnostic performance of emission tomography in the of recurrent prostate Urol. PubMed Scopus Google et clinical experience of PET/CT imaging in Prostate Cancer PubMed Scopus Google L. D. et for the of recurrent prostate cancer 18F-fluciclovine Nucl Med. PubMed Scopus Google L. et PET/CT in prostate cancer results of a J Nucl 2016; PubMed Scopus Google F.I. Nieh P.T. et prostate cancer detection with with J Nucl 2016; PubMed Scopus Google D.M. Nieh P.T. et emission tomography and emission tomography for recurrent prostate results of a clinical Urol. PubMed Scopus Google D.M. B. Nieh P.T. et of recurrent prostate with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 2011; PubMed Scopus Google L. et of the PET/CT with histopathology as reference Scholar or study the of the M. et 18F-fluciclovine emission tomography and imaging of prostate 2018; Scopus Google B. et and initial emission of recurrent prostate Urol. Scopus Google M. et study the PET for detection and of primary prostate J Nucl PubMed Scopus Google Scholar and for the studies are in and The studies a of All studies were studies used tomography D.M. Nieh P.T. et of primary prostate acid FACBC) J Nucl Google H. Inoue Y. et performance and of NMK36 in primary prostate cancer: clinical J 2016; Scopus Google H. Y. et performance of 18F-fluciclovine PET/CT for lymph node metastases in patients with primary prostate cancer: a clinical J PubMed Scopus Google B. 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Y. et performance of 18F-fluciclovine PET/CT for lymph node metastases in patients with primary prostate cancer: a clinical J PubMed Scopus Google Scholar The sector-based sensitivity and specificity for the studies are in The literature search studies of patients with prostate cancer in systematic sector-based histopathology had been used to at 18F-fluciclovine For all 18F-fluciclovine PET was performed as of the assessment of primary prostate cancer: for for lymph and and lymph node was a in sensitivity and specificity among the In systematic studies that had systematic sector-based histopathology as reference are This is in to complete a 2 2 with and that calculation of sensitivity and specificity. The of other systematic sector-based histopathology is The authors of that are 2 tracers or modalities reference standard. the detection where are as treatment based on is All studies that the for systematic review were performed in patients with known primary prostate The main from the studies tumor localization was high sensitivity and in specificity. However, are factors that to the high sensitivity that the to other the that all patients had prostate in has 18F-fluciclovine to tumor (Fig. the for is a and and is for sensitivity and specificity. In a as screening for prostate the a for in to and the of the H. Inoue Y. et performance and of NMK36 in primary prostate cancer: clinical J 2016; Scopus Google I. A. et of PET/CT and in to prostate cancer patients J Nucl 2018; 45: PubMed Scopus Google Scholar specificity The study of and H. Inoue Y. et performance and of NMK36 in primary prostate cancer: clinical J 2016; Scopus Google Scholar of primary and the prostate into This to in combination with to the high specificity. and I. A. et of PET/CT and in to prostate cancer patients J Nucl 2018; 45: PubMed Scopus Google Scholar high specificity for imaging for that the information from imaging was the for the high The main from the studies primary lymph node metastases was high specificity but low This that a of tumor is in for the lymph node metastases to be at 18F-fluciclovine This is and M. et PET/CT for in patients with to high primary prostate Urol. 2020; Scopus Google Scholar that the detection was to the of the for with for of or and B. M. et for lymph node in prostate cancer Radiol. 2018; PubMed Scopus Google Scholar also a and In a study of lymph and M. et in lymph detection with PubMed Scopus Google Scholar that most metastases were or This and H. Inoue Y. et performance and of NMK36 in primary prostate cancer: clinical J 2016; Scopus Google Scholar detect of the lymph node metastases in of At present, the Food and Drug Administration for 18F-fluciclovine PET is with recurrence after local Food and Drug Administration FDA Approves new diagnostic imaging agent to detect recurrent prostate cancer.https://fda.gov/news-events/press-announcements/fda-approves-new-diagnostic -imaging-agent-detect-recurrent-prostate-cancerGoogle Scholar the several studies have of 18F-fluciclovine PET in and to offer a cancer detection for disease and F. et of and in detection of recurrent prostate cancer in J Radiol. 2018; Full Text Full Text PDF PubMed Scopus (22) Google et clinical experience of PET/CT imaging in Prostate Cancer PubMed Scopus Google L. D. et for the of recurrent prostate cancer 18F-fluciclovine Nucl Med. PubMed Scopus Google L. et PET/CT in prostate cancer results of a J Nucl 2016; PubMed Scopus Google D.M. Nieh P.T. et emission tomography and emission tomography for recurrent prostate results of a clinical Urol. PubMed Scopus Google L. et of the PET/CT with histopathology as reference Scholar The diagnostic performance has been to be to that of F.I. Nieh P.T. et prostate cancer detection with with J Nucl 2016; PubMed Scopus Google Scholar F. et of and in detection of recurrent prostate cancer in J Radiol. 2018; Full Text Full Text PDF PubMed Scopus (22) Google Scholar L. et PET/CT in prostate cancer results of a J Nucl 2016; PubMed Scopus Google Scholar and emission D.M. Nieh P.T. et emission tomography and emission tomography for recurrent prostate results of a clinical Urol. PubMed Scopus Google Scholar The of systematic sector-based histopathology as reference these studies for the systematic In the clinical of is to systematic For local recurrence in the are recurrence after is as recurrence the and with salvage or recurrence after primary therapy to treatment systematic prostate prostatectomy, is performed because of of However, for lymph is to the 2 2 lymph node as reference standard. The authors studies in the recurrence but in the primary 1). studies of 18F-fluciclovine in the recurrence L. et PET/CT in prostate cancer results of a J Nucl 2016; PubMed Scopus Google D.M. Nieh P.T. et emission tomography and emission tomography for recurrent prostate results of a clinical Urol. PubMed Scopus Google Scholar that and the are on study and reference standard. and D.M. Nieh P.T. et emission tomography and emission tomography for recurrent prostate results of a clinical Urol. PubMed Scopus Google Scholar high sensitivity and specificity, and L. et PET/CT in prostate cancer results of a J Nucl 2016; PubMed Scopus Google Scholar imaging in of the For metastases is to the of In imaging is used to treatment of disease and to patients for focal treatment. The clinical of imaging be sensitivity and in these Clinical and survival are recent review in that the PET prostate-specific antigen has and for prostate cancer assessment because of sensitivity and specificity a of et on imaging and in prostate 2018; Full Text Full Text PDF PubMed Scopus Google Scholar The authors performed an systematic literature search for et PET for assessment of primary and recurrent prostate cancer with histopathology as reference – a systematic review and Clin. Google Scholar to search for The search 14 studies for primary for primary lymph and for lymph node are 2 studies that and in the in recurrence B. R. et of 18F-fluciclovine with in recurrence of prostate cancer in Nucl Med. PubMed Scopus Google J. F. M. et and in patients with recurrence after a imaging Full Text Full Text PDF PubMed Scopus Google Scholar and B. R. et of 18F-fluciclovine with in recurrence of prostate cancer in Nucl Med. PubMed Scopus Google Scholar in a study of patients that 18F-fluciclovine had a detection for local the results for disease and metastases were to In study of and J. F. M. et and in patients with recurrence after a imaging Full Text Full Text PDF PubMed Scopus Google Scholar a detection for local but as high for lymph and for for of these studies the of reviews because of the of systematic sector-based The authors that is for of of the 2 the of for is for In literature the PET tracer 18F-fluciclovine in patients with prostate a studies that had systematic sector-based histopathology calculation of sensitivity and specificity. In primary the sensitivity was but the specificity was limited. In primary lymph the sensitivity was The authors that have of that to the subject of the