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Randomized Controlled Trial
. 2014 Dec 20;32(36):4066-72.
doi: 10.1200/JCO.2013.52.8505. Epub 2014 Nov 10.

Can urinary PCA3 supplement PSA in the early detection of prostate cancer?

John T Wei  1 , Ziding Feng  2 , Alan W Partin  2 , Elissa Brown  2 , Ian Thompson  2 , Lori Sokoll  2 , Daniel W Chan  2 , Yair Lotan  2 , Adam S Kibel  2 , J Erik Busby  2 , Mohamed Bidair  2 , Daniel W Lin  2 , Samir S Taneja  2 , Rosalia Viterbo  2 , Aron Y Joon  2 , Jackie Dahlgren  2 , Jacob Kagan  2 , Sudhir Srivastava  2 , Martin G Sanda  2
Affiliations
Randomized Controlled Trial

Can urinary PCA3 supplement PSA in the early detection of prostate cancer?

John T Wei et al. J Clin Oncol. .

Abstract

Purpose: Given the limited sensitivity and specificity of prostate-specific antigen (PSA), its widespread use as a screening tool has raised concerns for the overdiagnosis of low-risk and the underdiagnosis of high-grade prostate cancer. To improve early-detection biopsy decisions, the National Cancer Institute conducted a prospective validation trial to assess the diagnostic performance of the prostate cancer antigen 3 (PCA3) urinary assay for the detection of prostate cancer among men screened with PSA.

Patients and methods: In all, 859 men (mean age, 62 years) from 11 centers scheduled for a diagnostic prostate biopsy between December 2009 and June 2011 were enrolled. The primary outcomes were to assess whether PCA3 could improve the positive predictive value (PPV) for an initial biopsy (at a score > 60) and the negative predictive value (NPV) for a repeat biopsy (at a score < 20).

Results: For the detection of any cancer, PPV was 80% (95% CI, 72% to 86%) in the initial biopsy group, and NPV was 88% (95% CI, 81% to 93%) in the repeat biopsy group. The addition of PCA3 to individual risk estimation models (which included age, race/ethnicity, prior biopsy, PSA, and digital rectal examination) improved the stratification of cancer and of high-grade cancer.

Conclusion: These data independently support the role of PCA3 in reducing the burden of prostate biopsies among men undergoing a repeat prostate biopsy. For biopsy-naive patients, a high PCA3 score (> 60) significantly increases the probability that an initial prostate biopsy will identify cancer.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
Standards for Reporting of Diagnostic Accuracy flow diagram. ASAP, atypical small acinar proliferation; HGPIN, high-grade prostate intraepithelial neoplasia; PCA3, prostate cancer antigen 3; TRUS, transrectal ultrasound.
See this image and copyright information in PMC

Comment in

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