In a preliminary study of 453 men scheduled for prostate biopsy, researchers found that the test predicted a positive biopsy significantly more accurately than did serum prostate-specific antigen (PSA) alone or in combination with other clinical predictors. The research team, led by James Amberson, MD, reported that urine testing had 87% specificity and 39% sensitivity and correlated with biopsy results and Gleason score.

In a second preliminary study of a biopsy cohort of 623 men and a prostatectomy cohort of 142 men, the urine test predicted biopsy results and clinically significant disease on biopsy. Moreover, in the prostatectomy cohort, the urine test predicted high Gleason score, upgrading of Gleason score between biopsy and excision, larger tumor size, and clinically significant disease. Researchers reported that the urine test demonstrated improved accuracy by approximately 10% compared to standard clinical risk predictors.

According to the press release announcing the findings, one disadvantage  ofthe test may be that its target is present in only about half of prostate cancers.

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Both studies were presented at the 2010 ASCO Genitourinary Cancers Symposium.