BACKGROUND. Overexpression of the c-erbB-2 oncogene has been implicate
d in the development and/or prognosis of several human carcinomas, inc
luding that of the prostate. Recently, c-erbB-2 protein was found to b
e released in the circulation. The present study was undertaken to stu
dy the significance of serum c-erbB-2 protein determination in men wit
h prostate cancer. METHODS. Serum c-erbB-2 protein determination was p
erformed via immunoradiometric assay using two monoclonal antibodies t
hat react with the extracellular domain of the protein. The study popu
lation consisted of 71 untreated prostate cancer patients. Of those, 3
3 with stage D2 disease entered a follow-up study. As control, serum c
-erbB-2 protein levels were determined in 92 patients with benign pros
tatic hypertrophy. In addition, elevations of c-erbB-2 protein were ex
amined in patients with various disease statuses: clinically well cont
rolled (28 patients), disease progression (24 patients), and end-stage
disease (17 patients). RESULTS. Elevation of serum c-erbB-2 protein l
evel was observed in patients in advanced stages, such as stage D2 dis
ease (30%), disease progression (42%), and end-stage disease (82.4%).
In the follow-up study, patients with an elevated c-erbB-2 level had a
significantly shorter interval to disease progression than did those
with a normal level. CONCLUSIONS. The results suggest that c-erbB-2 ca
n be used as a biomarker to identify a malignant subgroup in prostate
cancer. (C) 1997 Wiley-Liss, Inc.