BAY 1075553 PET-CT for Staging and Restaging Prostate Cancer Patients: Comparison with [18F] Fluorocholine PET-CT (Phase I Study)

Mol Imaging Biol. 2015 Jun;17(3):424-33. doi: 10.1007/s11307-014-0800-x.

Abstract

Purpose: (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.

Procedures: 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.

Publication types

  • Clinical Trial, Phase I
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Bone Marrow / pathology
  • Choline / analogs & derivatives
  • Choline / chemistry
  • Fluorodeoxyglucose F18 / chemistry
  • Glutarates / chemistry*
  • Humans
  • Lymphatic Metastasis / pathology
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Organophosphonates / chemistry*
  • Positron-Emission Tomography
  • Prospective Studies
  • Prostate-Specific Antigen / metabolism*
  • Prostatic Neoplasms / diagnostic imaging*
  • Radiometry
  • Sensitivity and Specificity
  • Tomography, X-Ray Computed

Substances

  • 2-fluoro-4-phosphonomethylpentanedioic acid
  • Glutarates
  • Organophosphonates
  • Fluorodeoxyglucose F18
  • fluorocholine
  • Prostate-Specific Antigen
  • Choline