Published online Mar 24, 2015. doi: 10.5410/wjcu.v4.i1.68
Peer-review started: May 18, 2014
First decision: June 26, 2014
Revised: October 16, 2014
Accepted: November 17, 2014
Article in press: November 19, 2014
Published online: March 24, 2015
Processing time: 311 Days and 12.3 Hours
AIM: To assess the role of PCA3 urine test in the management of patients with suspected prostate cancer after repeat negative prostate biopsies.
METHODS: Patients with suspected prostate cancer either due to high or rising prostate specific antigen (PSA) levels and with a history of prostate biopsy who were candidates for repeat procedure were prospectively recruited to undergo PCA3 urine test. The recommendations on further management including the decision whether to proceed or not to the biopsy were made based on the PCA3 score. Patients’ adherence with the recommendations and influence of the PCA3 test on clinical decision making were assessed. The contribution of the multivariate model was measured with a decision curve analysis.
RESULTS: Three hundred and fifty-six patients were recruited to the study and underwent the PCA3 test. Twenty-six percent of 263 patients underwent prostate biopsy despite the low risk designation by PCA3 and 30% of 93 men did not proceed to biopsy despite a high risk result, rendering overall adherence of 73%. The variables that significantly correlated with adherence were positive family history of prostate cancer and PSA more than 10 ng/mL. Pre-test clinical stage, the number and the results of previous biopsies were not associated with the adherence. The decision curve analysis gave identical results for cut-off points of 25 and 35. On multivariate analysis the model that included PCA3 score, serum PSA, family history and result of the previous biopsy best performed with Area Under the Curve of 0.77.
CONCLUSION: PCA3 urine test markedly outperforms PSA in a repeat biopsy setting. Urologists and patients demonstrate substantial confidence in this analysis and tend to follow its recommendations.
Core tip: PCA3 is a molecular urine test, which is performed in patients with high risk for prostate cancer. In this international prospective study we demonstrate that it has better performance than routine serum prostate specific antigen test in men with previously negative prostate biopsies. We also show that patients and physicians tend to follow the recommendations for this test.