title: Effectiveness of two ultrasound-guided transrectal biopsy schemes in the diagnosis of prostate cancer. A randomized study.
abstract: OBJECTIVE
  To determine whether a 10-core prostate biopsy scheme is superior to the sextant scheme in diagnosing prostate cancer in patients programmed for a first biopsy, with negative rectal digital examination and PSA between 3.5-20 ng/ml.
  
  
  METHODS
  A randomized prospective study was performed comparing two prostate biopsy schemes, with randomization stratification according to prostate volume (< or = 50 ml and > 50 ml). Sample size predetermination yielded a minimum of 304 patients in order to achieve the primary objective. Statistical analysis was carried out on an intent-to-treat basis, using the chi-squared test and uni- and multivariate analysis via logistic regression.
  
  
  RESULTS
  Cancer was detected in 27.3% of the cases. A significant association was observed between cancer diagnosis and age (p=0.03), prostate volume (p=0.0001) and ultrasound nodule identification (p=0.0001). No correlation was observed with the total number of cores in the series (p=0.37) or with prostate volume < or = 50 ml (p=0.87) or > 50 ml (p=0.09). In the multivariate analysis, age > 70 years (p=0.005), prostate volume < or = 50 ml (p=0.001), and ultrasound nodule identification (p=0.003) were identified as independent variables associated to cancer diagnosis.
  
  
  CONCLUSIONS
  No statistically significant differences were found between the two prostate biopsy schemes. In glands over 50 ml in size, the sextant scheme may prove to be insufficient.
authors.affiliation: Urology Department, Hospital General Universitario Gregorio Marañon, Madrid, Spain. felipeherranz@telefonica.net
authors.forename: Felipe
authors.initials: F
authors.lastname: Herranz Amo
authors.forename: José
authors.initials: J
authors.lastname: Jara Rascón
authors.forename: María José
authors.initials: MJ
authors.lastname: Cancho Gil
authors.forename: Juan
authors.initials: J
authors.lastname: Tabares Jiménez
authors.forename: Roberto
authors.initials: R
authors.lastname: Molina Escudero
authors.forename: Carlos
authors.initials: C
authors.lastname: Hernández Fernández
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology*; D014463:Ultrasonography