title: BAY 1075553 PET-CT for Staging and Restaging Prostate Cancer Patients: Comparison with [18F] Fluorocholine PET-CT (Phase I Study).
abstract: OBJECTIVE
  (2RS,4S)-2-[(18)F]Fluoro-4-phosphonomethyl-pentanedioic acid (BAY1075553) shows increased uptake in prostate cancer cells. We compared the diagnostic potential of positron emission tomography (PET)-X-ray computed tomography (CT) imaging using BAY1075553 versus [(18)F]f luorocholine (FCH) PET-CT.
  
  
  METHODS
  Twelve prostate cancer patients (nine staging, three re-staging) were included. The mean prostate-specific antigen in the primary staging and re-staging groups was 21.5 ± 12 and 73.6 ± 33 ng/ml, respectively. Gleason score ranged from 5-9. In nine patients imaged for pre-operative staging, the median Gleason score was 8 (range, 7-9). PET acquisition started with dynamic PET images in the pelvic region followed by static whole-body acquisition. The patients were monitored for 5-8 days afterward for adverse events.
  
  
  RESULTS
  There were no relevant changes in laboratory values or physical examination. Urinary bladder wall received the largest dose equivalent 0.12 mSv/MBq. The whole-body mean effective dose was 0.015 mSv/MBq. There was a significant correlation between detected prostatic lesions by the two imaging modalities (Kappa = 0.356, P < 0.001) and no significant difference in sensitivity (P = 0.16) and specificity (P = 0.41). The sensitivity and specificity of PET imaging using BAY1075553 for lymph node (LN) staging was 42.9 % and 100 %, while it was 81.2 % and 50 % using FCH. The two modalities were closely correlated regarding detection of LNs and bone metastases, although BAY1075553 failed to detect a bone marrow metastasis. Degenerative bone lesions often displayed intense uptake of BAY1075553.
  
  
  CONCLUSIONS
  BAY1075553 PET-CT produced no adverse effects, was well tolerated, and detected primary and metastatic prostate cancer. FCH PET-CT results were superior, however, with respect to detecting LN and bone marrow metastases.
authors.affiliation: Department of Nuclear Medicine and Endocrinology, PET-CT Center Linz, St. Vincent's Hospital, Seilerstaette 4, Linz, 4020, Austria, mohsen.beheshti@bhs.at.
authors.forename: Mohsen
authors.initials: M
authors.lastname: Beheshti
authors.forename: Thomas
authors.initials: T
authors.lastname: Kunit
authors.forename: Silke
authors.initials: S
authors.lastname: Haim
authors.forename: Rasoul
authors.initials: R
authors.lastname: Zakavi
authors.forename: Christian
authors.initials: C
authors.lastname: Schiller
authors.forename: Andrew
authors.initials: A
authors.lastname: Stephens
authors.forename: Ludger
authors.initials: L
authors.lastname: Dinkelborg
authors.forename: Werner
authors.initials: W
authors.lastname: Langsteger
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Loidl
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001853:Bone Marrow / Q000473:pathology; D002794:Choline / Q000031:analogs & derivatives / Q000737:chemistry; D019788:Fluorodeoxyglucose F18 / Q000737:chemistry; D005977:Glutarates / Q000737:chemistry*; D006801:Humans; D008207:Lymphatic Metastasis / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D063065:Organophosphonates / Q000737:chemistry*; D049268:Positron-Emission Tomography; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000378:metabolism*; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging*; D011874:Radiometry; D012680:Sensitivity and Specificity; D014057:Tomography, X-Ray Computed
chemical_list: C000589485:2-fluoro-4-phosphonomethylpentanedioic acid; D005977:Glutarates; D063065:Organophosphonates; D019788:Fluorodeoxyglucose F18; C514960:fluorocholine; D017430:Prostate-Specific Antigen; D002794:Choline