Adult urologyPCA3 Molecular Urine Assay for Prostate Cancer in Men Undergoing Repeat Biopsy
Section snippets
Material and Methods
The urine samples were obtained from three North American sites: Laval University (Quebec City, Quebec, Canada), Urological Sciences Research Foundation (Los Angeles, Calif), and the University of Washington School of Medicine (Seattle, Wash). The respective institutional review boards approved the study protocol, and all study subjects provided written informed consent. The specimens were collected from April 2004 to January 2006.
The study population consisted of 233 consecutive men with serum
Results
For the subject group studied, 226 of 233 specimens yielded sufficient RNA for analysis, corresponding to an informative specimen rate of 97%. For the 226 subjects with informative specimens, 60 repeat biopsies were positive for CaP and 166 were negative. All CaP cases found were Gleason grade 6 (65%) or 7 (35%).
To assess the ability of the PCA3 assay to predict the prostate biopsy outcome, receiver operating characteristic (ROC) curve analysis was performed using the biopsy result as the
Comment
CaP will have been diagnosed in approximately 230,000 U.S. men during 2006.12 The great majority of these men will have undergone prostate biopsy because of an elevated serum PSA level. The positive predictive value of a serum PSA level of 4.0 ng/mL or more, the biopsy trigger currently recommended by the American Urological Association,13 is approximately 24% for men in their seventh decade.14 Thus, about 1 million U.S. men will have undergone a prostate biopsy in 2006 to detect CaP in one
Conclusions
PCA3 gene overexpression is detectable in urine, providing the basis for a specific CaP test. Improved PCA3 assay methods—applied in this study in 233 men with serum PSA levels greater than 2.5 ng/mL and previous negative biopsy findings—allowed for the prediction of CaP on repeat biopsy with a specificity of 72%, sensitivity of 58%, and an odds ratio of 3.6, using a PCA3 score cutpoint of 35 (copies of PCA3 per copy of PSA mRNA). The risk of positive biopsy findings correlated with the
Acknowledgment
To Seongjoon Koo, Art Weber, and James Tatlow for help in trial management and data analysis, and Dr. Robert Vessella for help and guidance with specimen collection, study design, and data analysis.
References (15)
- et al.
Prostate-specific antigen: update 2006
Urology
(2006) - et al.
The prostate specific antigen era in the United States is over for prostate cancer: what happened in the last 20 years?
J Urol
(2004) - et al.
DD3(PCA3)-based molecular urine analysis for the diagnosis of prostate cancer
Eur Urol
(2003) - et al.
DD3PCA3 RNA analysis in urine—a new perspective for detecting prostate cancer
Eur Urol
(2004) - et al.
The role of prostate needle biopsy in evaluation of chemopreventive agents
Urology
(2001) - et al.
Serial biopsy results in prostate cancer screening study
J Urol
(2002) - et al.
Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/ml or lower
JAMA
(2005)
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- 1
W. J. Ellis has served as a speaker, paid consultant, and study investigator for Gen-Probe.
- 2
Y. Fradet has served as a speaker, paid consultant, and study investigator for Gen-Probe and DiagnoCure.
- 3
L. S. Marks has served as a speaker, paid consultant, and study investigator for Gen-Probe and Beckman-Coulter, Inc.