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Clinical Trial
. 2009 Sep 1;115(17):3879-86.
doi: 10.1002/cncr.24447.

Rational approach to implementation of prostate cancer antigen 3 into clinical care

Rou Wang  1 , Arul M Chinnaiyan, Rodney L Dunn, Kirk J Wojno, John T Wei
Affiliations
Clinical Trial

Rational approach to implementation of prostate cancer antigen 3 into clinical care

Rou Wang et al. Cancer. .

Abstract

Background: Prostate cancer antigen 3 (PCA3) encodes a prostate-specific messenger ribonucleic acid (mRNA) that serves as the target for a novel urinary molecular assay for prostate cancer detection. The objective of the current study was to evaluate the ability of PCA3, added to measurements of serum prostate-specific antigen (PSA), to predict cancer detection by extended template biopsy.

Methods: Between September 2006 and December 2007, whole urine samples were collected after attentive digital rectal examinations from 187 men before they underwent ultrasound-guided, 12-core prostate biopsy in a urology outpatient clinic. Urine PCA3/PSA mRNA ratio scores were measured within 1 month, and serum PSA was measured within 6 months prior to biopsy. Those measurements were related to cancer-positive biopsies.

Results: Overall, 87 of 187 biopsies (46.5%) were positive for cancer. The sensitivity and specificity of a PCA3 score > or =35 for positive biopsy were 52.9% and 80%, respectively, and the positive and negative predictive values were 69.7% and 66.1%, respectively. By using receiver operating characteristic curve analysis, PSA alone resulted in an area under the curve (AUC) of 0.63 for prostate cancer detection; whereas a combined PSA and PCA3 score resulted in an AUC of 0.71. The likelihood of prostate cancer detection rose with increasing PCA3 score ranges (P > .0001), providing possible PCA3 score parameters for stratification into groups at low risk, moderate risk, high risk, and very high risk for a positive biopsy.

Conclusions: Adding PCA3 to serum PSA improved prostate cancer prediction. The use of PCA3 in a clinical setting may help to stratify patients according to their risk for biopsy and cancer detection, although a large-scale validation study will be needed to address assay standardization, optimal cutoff values, and appropriate patient populations.

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Figures

Figure 1
Figure 1. ROC Curve Analysis for serum PSA versus serum PSA + urine PCA3
Receiver operating characteristic (ROC) curve comparing serum PSA alone (dashed line) versus serum PSA + urine PCA3 score (solid line) as a predictor of positive prostate biopsy. Area under the curve (AUC) for serum PSA alone was 0.63 versus 0.71 for serum PSA + urine PCA3 score.
Figure 2
Figure 2. PCA3 Score and Relation to %Positive Biopsy
There is a significant rise in the proportion of positive biopsies with increasing PCA3 score ranges (p>0.0001). A PCA3 score of 35 is used as a cut-off.
See this image and copyright information in PMC

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