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Introduction & Objectives: PSA ratio (PSAr) and PSA density (PSAd) are derivates of PSA which have been introduced to improve sensibility and specifity of total PSA for values between 4 and 10 ng/ml. In this work we analyzed the predictive accuracy of PSAr and PSAd for different ranges of PSA, and we assessed the corresponding values of their cut offs. Material & Methods: A cohort of 1658 of not selected patients (pts) underwent transrectal prostatic biopsy; we performed a sextant scheme biopsy plus 2/3 further cores laterally on each lobe; in high volume prostates, number of cores was increased according to Vienna nomogram; moreover in case of re-biopsy at least 2 cores were added in the transition zone. Pts were stratified in 3 groups: PSA ≤4 ng/ml (group 1, n= 183), PSA 4 - 10 ng/ml (group 2, n= 1043), PSA >10 ng/ml (group 3, n= 432). Indications for biopsy were: in group 1 familiarity for prostate cancer, a suspicious clinical lesion (digital rectal exploration and/or hypoechoic lesion on ultrasound) or PSA velocity > 0.75 ng/ml/year ; in group 2, a suspicious clinical lesion (digital rectal exploration and/or hypoechoic lesion on ultrasound) or a PSAr < 20%; in group 3 the value of total PSA for itself was considered sufficient for biopsy. Differences of means of prostate volumes were valuated with ANOVA test. A univariate analysis was constructed for correlating PSAr and PSAd with the outcome of biopsy; receiving operating curve (ROC) was used to test the predictive accuracy of derivates of PSA and to identify the optimal cut offs. Results: The detection rates were 31.5%, 31% and 40% respectively in group 1, 2 and 3. Mean prostate volume on ultrasound was significantly different among the 3 groups (40cc vs 53cc vs 64cc; p:0.001). At univariate analysis PSAd was significantly associated to a positive biopsy among all the groups (respectively in group 1,2 and 3: p: 0.005, 0.001 and 0.001); PSAr was significantly associated to a positive biopsy in group 2 and 3 (p: 0.001 e 0.006), but not in group 1 (p: 0.335). Area Under ROC (AUC) of PSAd was higher than that of PSAr on all the 3 groups (respectively AUC: 0.70 vs 0.57; 0,71 vs 0.60; 0.78 vs 0.64); cut off values of PSAd were 0.10, 0.14 and 0.33 ng/ml/gr, and of PSAr were 14%, 13% e 10%, respectively in group 1,2 and 3. Sensibility rates at the different cut off values of PSAd were higher than that of PSAr (group 1: 70 vs 52%; group 2: 74 vs 51%; group 3: 66 vs 53%), whereas specificity rates were similar (68 vs 75%; 62 vs 68%; 80 vs 77%) Conclusions: PSAd has a higher sensibility than PSAr; PSAd could be more useful than PSAr to give indications for biopsy, above all using different cut off values according to total PSA ranges: this clinical approach could be recommended for pts with PSA ≤4 ng/ml, where, for the smaller volume gland of these pts, variability of PSAd is more sensitive in case of cancer. A value of PASd >0.10 ng/ml/gr may be used to select patient for prostate biopsy.

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