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Journal

PROGENSA�PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: A prospective multicenter clinical study

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Published:25th Mar 2020
Purpose: To evaluate the clinical utility of the PROGENSA PCA3 Assay for the prediction of repeat prostate biopsy outcome. Materials and Methods: Men with at least one prior negative prostate biopsy who, based upon best clinical judgment, were scheduled for repeat prostate biopsy were enrolled at 14 centers. Whole blood and post-digital rectal exam urine samples were collected prior to =12 core, extended template transrectal biopsy. Urinary PCA3 Scores and biopsy outcome were assessed using logistic regression (LR) analysis that also included age, race, serum PSA level, clinical stage, family history of prostate cancer, and the number of previous negative biopsies sessions. Results: A total of 466 men were included in the study. Prostate cancer was identified in 21.9% of subjects. A PCA3 Score cutoff of 25 yielded 77.5% sensitivity, 57.1% specificity, negative predictive value of 90%, and positive predictive value of 33.6%. In the multivariable LR analysis, men with PCA3 Scores <25 were 4.56 times as likely to have a negative repeat biopsy as men with pca3 scores>25. PCA3 Score significantly increased predictive accuracy of the LR model: at 90% sensitivity, addition of PCA3 Score to the model increased specificity, PPV, and NPV by 22.6%, 6.4%, and 7.1% respectively, relative to the model without PCA3 Score. Conclusions: The PCA3 Score supplements serum PSA and other clinical information for more accurate prediction of repeat biopsy outcome, thus providing clinicians and patients with independent, clinically useful information to make more informed repeat biopsy decisions.

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