title: Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer.
abstract: Sensitive detection of cancer foci in men experiencing biochemical recurrence following initial treatment of prostate cancer is of great clinical significance with a possible impact on subsequent treatment choice. We describe a multisite experience of the efficacy and safety of the positron emission tomography/computerized tomography agent fluciclovine (18F) after biochemical recurrence.
  
  
  
  A total of 596 patients underwent fluciclovine (18F) positron emission tomography/computerized tomography at 4 clinical sites. Detection rate determinations were stratified by the baseline prostate specific antigen value. Diagnostic performance was assessed against a histological reference standard in 143 scans.
  
  
  
  The subject level fluciclovine (18F) positron emission tomography/computer tomography detection rate was 67.7% (403 of 595 scans). Positive findings were detected in the prostate/bed and pelvic lymph node regions in 38.7% (232 of 599) and 32.6% of scans (194 of 596), respectively. Metastatic involvement outside the pelvis was detected in 26.2% of scans (155 of 591). The subject level detection rate in patients in the lowest quartile for baseline prostate specific antigen (0.79 ng/ml or less) was 41.4% (53 of 128). Of these patients 13 had involvement in the prostate/bed only, 16 had pelvic lymph node involvement without distant disease and 24 had distant metastases. The positive predictive value of fluciclovine (18F) positron emission tomography/computerized tomography scanning for all sampled lesions was 62.2%, and it was 92.3% and 71.8% for extraprostatic and prostate/bed involvement, respectively. Fluciclovine (18F) was well tolerated and the safety profile was not altered following repeat administration.
  
  
  
  Fluciclovine (18F) is well tolerated and able to detect local and distant prostate cancer recurrence across a wide range of prostate specific antigen values.
authors.affiliation: Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway. Electronic address: bat@uus.no.
authors.forename: Tore
authors.initials: T
authors.lastname: Bach-Gansmo
authors.affiliation: Nuclear Medicine, Azienda ospedaliero-universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Nanni
authors.affiliation: Department of Urology, Emory University, Atlanta, Georgia.
authors.forename: Peter T
authors.initials: PT
authors.lastname: Nieh
authors.affiliation: Nuclear Medicine, Azienda ospedaliero-universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Zanoni
authors.affiliation: Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.
authors.forename: Tronde Velde
authors.initials: TV
authors.lastname: Bogsrud
authors.affiliation: Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.
authors.forename: Heidi
authors.initials: H
authors.lastname: Sletten
authors.affiliation: Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.
authors.forename: Katrine Andersen
authors.initials: KA
authors.lastname: Korsan
authors.affiliation: Department of Nuclear Medicine and Radiology, Aleris Healthcare, Oslo, Norway.
authors.forename: J
authors.initials: J
authors.lastname: Kieboom
authors.affiliation: Department of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.
authors.forename: Funmilayo I
authors.initials: FI
authors.lastname: Tade
authors.affiliation: Department of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.
authors.forename: Oluwaseun
authors.initials: O
authors.lastname: Odewole
authors.affiliation: Blue Earth Diagnostics, Oxford, United Kingdom.
authors.forename: Albert
authors.initials: A
authors.lastname: Chau
authors.affiliation: Blue Earth Diagnostics, Oxford, United Kingdom.
authors.forename: Penelope
authors.initials: P
authors.lastname: Ward
authors.affiliation: Department of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.
authors.forename: Mark M
authors.initials: MM
authors.lastname: Goodman
authors.affiliation: Nuclear Medicine, Azienda ospedaliero-universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Fanti
authors.affiliation: Department of Radiology and Imaging Sciences, Emory University, Atlanta, Georgia.
authors.forename: David M
authors.initials: DM
authors.lastname: Schuster
authors.affiliation: Department of Nuclear Medicine and Radiology, Aleris Healthcare, Oslo, Norway; Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.
authors.forename: Frode
authors.initials: F
authors.lastname: Willoch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002264:Carboxylic Acids; D003503:Cyclobutanes; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000072078:Positron Emission Tomography Computed Tomography; D011237:Predictive Value of Tests; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000000981:diagnostic imaging* / Q000473:pathology*; D012189:Retrospective Studies
chemical_list: D002264:Carboxylic Acids; D003503:Cyclobutanes; C117460:fluciclovine F-18; D017430:Prostate-Specific Antigen
keywords: emission-computed; fluciclovine F-18; local; neoplasm recurrence; positron-emission tomography; prostatic neoplasms; tomography