Objectives: To determine the effectiveness and safety of saturation biopsies for prostate cancer detection of and to identify predictive variables for cancer.

Methods: We conducted a retrospective transversal study in which we analyzed 144 saturation biopsies (January '06 - July '09).

Inclusion Criteria: at least two sets of biopsies without evidence of malignancy and Prostate Specific Antigen (PSA)levels >10 ng/ml or PSA kinetics suggestive of malignancy (rate >0.75 ng/ml/year)and patients with atypia in a previous biopsy.The variables analyzed were: age, abnormal digital rectal examination (DRE), total PSA, free/total PSA ratio, prostate volume, PSA density, previous histopathology, number of cylinders obtained and complications. Statistical analysis was performed using the Chi-square test, Student's t-test and logistic regression.

Results: Mean age was 66 years (SD ± 6.4), mean total PSA 14.4 ng/ml (SD ± 12.6), mean free/total PSA ratio 0.09 (SD ± 0.09), mean prostate volume 61.6 cc (SD ± 27.4), mean PSA density 0.27 (SD ± 0.26) and mean number of cylinders obtained 30.45 (SD ± 3.8). We diagnosed 32% of the patients with prostatic adenocarcinoma. We observed PSA density was higher in the prostate cancer group, 0.39 (SD ± 0.36), compared to 0.21 (SD ± 0.18) in patients without cancer (p=0.003). Adenocarcinoma was found in 58% of the biopsies in patients with suspicious DRE, compared to 28% with normal DRE (p=0.009). Mean prostate volume in the prostate cancer group was 52.5 (SD ± 24.7)compared to 66.0 (SD ± 27.7)in the group without cancer (p=0.006). In the multivariate analysis, the PSA density (p=0.02; 95% CI 1.36 - 37.36) was the only variable that independently predicted the presence of adenocarcinoma. No statistically significant differences were found in either univariate or multivariate analysis for the remaining variables analyzed. The incidence of complications was similar to that described in the literature for other series.

Conclusions: Saturation biopsy is safe and effective for detection of prostate cancer. PSA density was the only factor that was shown to be independent predictive variable for tumor diagnosis.

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