A prospective randomized trial comparing the Vienna nomogram and a ten-core prostate biopsy protocol : effect on cancer detection rate

Abstract

We performed a prospective randomized study of men undergoing prostate biopsy randomized to a Vienna nomogram protocol (group A) or a 10-core protocol (group B). The results suggest that the use of the Vienna nomogram does not significantly increase the overall cancer detection rate compared with a 10-core biopsy scheme. Further prospective randomized studies, with adequate sample sizes, are needed to definitively determine the best prostate biopsy protocol. Background: We evaluated whether the Vienna nomogram increases the detection rate of transrectal ultrasoundguided prostate biopsy compared with a 10-core biopsy protocol. Patients and Methods: In the present prospective randomized study, men eligible for prostate biopsy were randomized to a Vienna nomogram protocol (group A) or a 10-core protocol (group B). They were further stratified according to age ( 65, > 65 but 70, and > 70 years) and prostate volume ( 30, > 30 but 50, > 50 but 70, and > 70 cm3 ). The cancer detection rate (CDR) was compared between the groups by logistic regression analysis, with adjustment for age as necessary, overall and with age and prostate volume stratification. Additional statistical analysis was performed with Fisher’s exact test for contingency tables and the Mann-Whitney U test for 2 independent samples. P < .05 was considered statistically significant. A subgroup analysis was performed for patients with serum prostate-specific antigen levels of 2 to 10 ng/mL. Results: From January 2009 to July 2010, 456 patients were enrolled, 237 to the Vienna nomogram group and 219 to the 10-core group. No significant differences were found in serum prostate-specific antigen or prostate volume between the 2 groups. Multivariate analysis with adjustment for age revealed no significant differences in CDR, with 42.6% in group A and 38.4% in group B (P ¼ .705). When stratified by age and prostate volume, no statistically significant differences were found in the CDR between the groups in all subclasses. Also, in the subgroup analysis, CDR was not significantly different, 37.9% versus 34.7% for groups A and B, respectively (P ¼ .891). Conclusion: These results study suggest that the use of the Vienna nomogram does not significantly increase the overall CDR compared with a 10-core biopsy scheme. Further prospective randomized studies, with adequate sample sizes, are needed to definitively determine the best prostate biopsy protocol.