title: A Prospective Randomized Trial Comparing the Vienna Nomogram and a Ten-Core Prostate Biopsy Protocol: Effect on Cancer Detection Rate.
abstract: 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 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.
  
  
  
  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.
authors.affiliation: 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: titopleitao@gmail.com.
authors.forename: Tito Palmela
authors.initials: TP
authors.lastname: Leitão
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal.
authors.forename: Joana
authors.initials: J
authors.lastname: Alfarelos
authors.affiliation: Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal.
authors.forename: Teresa
authors.initials: T
authors.lastname: Rodrigues
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Pereira E Silva
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal.
authors.forename: Rodrigo Miguel
authors.initials: RM
authors.lastname: Garcia
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal.
authors.forename: David
authors.initials: D
authors.lastname: Martinho
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal.
authors.forename: Anatoliy
authors.initials: A
authors.lastname: Sandul
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal.
authors.forename: Tiago
authors.initials: T
authors.lastname: Mendonça
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal.
authors.forename: Sérgio
authors.initials: S
authors.lastname: Pereira
authors.affiliation: Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal.
authors.forename: Tomé Matos
authors.initials: TM
authors.lastname: Lopes
mesh_terms: D000368:Aged; D062005:Biopsy, Large-Core Needle; D006801:Humans; D007610:Kallikreins / Q000097:blood; D008297:Male; D008875:Middle Aged; D049451:Nomograms; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology*; D011897:Random Allocation; D012680:Sensitivity and Specificity
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen
keywords: Nomograms; Prostate biopsy; Prostate cancer; Prostatic neoplasms; Ultrasonography