title: Phase IIa Clinical Trial of Trans-1-Amino-3-(18)F-Fluoro-Cyclobutane Carboxylic Acid in Metastatic Prostate Cancer.
abstract: OBJECTIVE
  We performed a phase IIa clinical trial of trans-1-amino-3-(18)F-fluoro-cyclobutane carboxylic acid (anti-(18)F-FACBC), a synthetic amino acid analog for PET, in patients with metastatic prostate cancer.
  
  
  METHODS
  The study subjects consisted of 10 untreated prostate cancer patients having lymph node and/or bone metastasis. Five patients underwent whole-body PET 5 and 30 min after intravenous injection of anti-(18)F-FACBC. The other five patients underwent 60 min dynamic PET of the pelvis. Safety assessment was performed before and 24 h after injection. PET/CT images were assessed visually, and time courses of anti-(18)F-FACBC uptake were evaluated from dynamic imaging.
  
  
  RESULTS
  Two mild adverse events were observed and resolved without treatment. All 10 patients showed increased accumulation of anti-(18)F-FACBC in the primary prostate lesion. CT revealed five enlarged lymph nodes indicating metastasis, and all showed increased uptake. Additionally, anti-(18)F-FACBC PET delineated unenlarged lymph nodes as hot spots. Anti-(18)F-FACBC PET demonstrated metastatic bone lesions, similar to conventional imaging. In one of two patients with lung metastasis, some lesions showed increased uptake. Regarding the time course, increased uptake of anti-(18)F-FACBC in the lesion was demonstrated immediately after injection, followed by gradual washout.
  
  
  CONCLUSIONS
  The results of this phase IIa clinical trial indicated the safety of anti-(18)F-FACBC in patients with prostate cancer and the potential of anti-(18)F-FACBC PET to delineate primary prostate lesions and metastatic lesions. This clinical trial was registered as JapicCTI-101326.
authors.affiliation: Department of Diagnostic Radiology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Inoue
authors.affiliation: Department of Diagnostic Radiology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Asano
authors.affiliation: Department of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Takefumi
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Department of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Tabata
authors.affiliation: Department of Radiology, Kitasato University Hospital, Sagamihara, Kanagawa, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Kikuchi
authors.affiliation: Department of Diagnostic Radiology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Reiko
authors.initials: R
authors.lastname: Woodhams
authors.affiliation: Department of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Baba
authors.affiliation: Department of Radiation Oncology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
keywords: Anti-18F-FACBC; Metastasis; Positron Emission Tomography; Prostate cancer