title: A validated strategy for side specific prediction of organ confined prostate cancer: a tool to select for nerve sparing radical prostatectomy.
abstract: OBJECTIVE
  Nerve sparing radical prostatectomy for prostate cancer should be restricted to patients who harbor tumors without capsular penetration. To our knowledge the selection criteria for nerve sparing radical prostatectomy are not clearly defined. We investigated a panel of preoperative tumor characteristics with respect to their ability to predict organ confined tumor growth for each lobe of the prostate to indicate unilateral or bilateral nerve sparing radical prostatectomy.
  
  
  METHODS
  Nine preoperative tumor characteristics in 278 patients with clinically localized prostate cancer were included in retrospective univariate and multivariate tree structured regression analysis. The association of clinical stage, serum prostate specific antigen (PSA), PSA density, and results of transrectal ultrasound and systematic sextant biopsy, including a quantitative assessment of cancer in the biopsies with organ confined tumor growth, was statistically evaluated. Except for serum PSA and PSA density preoperative characteristics were considered separately for each prostate lobe. Multivariate analysis results were validated prospectively in 353 patients.
  
  
  RESULTS
  On univariate analysis the number of positive biopsies was the most useful single parameter with a positive predictive value of 83% in 274 lobes and a negative predictive value of 55%, followed by mm. of tumor in the biopsy. Of all characteristics included in multivariate analysis only the number of biopsies with high grade cancer, the number of positive biopsies and serum PSA were independent for predicting organ confined cancer. When PSA was less than 10 ng./ml. and not more than 1 biopsy with high grade cancer was identified in a lobe, organ confined tumor growth was present in 86.1% of cases. On prospective validation the same criteria led to an 88.5% incidence of organ confined prostate cancer. Pooling the 2 most favorable groups led to 391 prostate lobes (70.8% of those investigated) with a positive predictive value of 82.1% (95% confidence interval 77.9% to 85.8%). Using the multivariate approach more prostate lobes were assigned to a favorable risk group than on univariate analysis. Clinical stage and simple Gleason grade did not contribute independent information for predicting organ confined disease.
  
  
  CONCLUSIONS
  Quantifying cancer and high grade cancer by systematic biopsy and serum PSA concentration are useful preoperative characteristics for predicting organ confined prostate cancer. Side specific analysis of these parameters is a flexible and reliable tool for selecting patients for nerve sparing radical prostatectomy.
authors.affiliation: Department of Urology and Institutes of Mathematics and Computer Science in Medicine, and Pathology University Hospital Eppendorf, Hamburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Graefen
authors.forename: A
authors.initials: A
authors.lastname: Haese
authors.forename: U
authors.initials: U
authors.lastname: Pichlmeier
authors.forename: P G
authors.initials: PG
authors.lastname: Hammerer
authors.forename: J
authors.initials: J
authors.lastname: Noldus
authors.forename: K
authors.initials: K
authors.lastname: Butz
authors.forename: A
authors.initials: A
authors.lastname: Erbersdobler
authors.forename: R P
authors.initials: RP
authors.lastname: Henke
authors.forename: U
authors.initials: U
authors.lastname: Michl
authors.forename: S
authors.initials: S
authors.lastname: Fernandez
authors.forename: H
authors.initials: H
authors.lastname: Huland
mesh_terms: D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D011467:Prostate / Q000294:innervation; D011468:Prostatectomy / Q000379:methods*; D011471:Prostatic Neoplasms / Q000473:pathology* / Q000601:surgery*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity