A Prospective Randomized Trial Comparing the Vienna Nomogram and a Ten-Core Prostate Biopsy Protocol: Effect on Cancer Detection Rate.

We evaluated whether the Vienna nomogram increases the detection rate of transrectal ultrasound-guided prostate biopsy compared with a 10-core biopsy protocol.

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 cm(3)). 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.

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 = .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 = .891).

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.

Clinical genitourinary cancer. 2016 Jun 23 [Epub ahead of print]

Tito Palmela Leitão, Joana Alfarelos, Teresa Rodrigues, Ricardo Pereira E Silva, Rodrigo Miguel Garcia, David Martinho, Anatoliy Sandul, Tiago Mendonça, Sérgio Pereira, Tomé Matos Lopes

Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal. Electronic address: ., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal., Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal., Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal.

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