title: Biopsy indication--a predictor of pathologic stage among men with preoperative serum PSA levels of 4.0 ng/mL or less and T1c disease.
abstract: OBJECTIVE
  To determine the indications for biopsy among men with a prostate-specific antigen (PSA) level of 4 ng/mL or less and T1c disease and whether the reason for biopsy correlated with the final pathologic stage. It is not uncommon for men to undergo radical prostatectomy (RP) with a prostate-specific antigen (PSA) level of 4 ng/mL or less and T1c disease.
  
  
  METHODS
  We examined the percentage of men with T1c disease and PSA level of 4.0 ng/mL or less undergoing RP over time. We identified 874 men with T1c prostate adenocarcinoma and PSA levels of 4 ng/mL or less who were treated with RP between 1994 and 2003. We excluded 72 patients who had received preoperative hormonal therapy and 86 patients for whom the reason for biopsy was unclear. The pathologic outcomes were compared between the various biopsy indication groups using analysis of variance.
  
  
  RESULTS
  The percentage of men with T1c disease and a PSA level of 4.0 ng/mL or less has steadily increased from 0% before 1990 to 19% in 2003. Among men treated between 1994 and 2003, the most common indication for biopsy was a spike in the PSA level to greater than their reference level before biopsy (n = 471, 66%), although in all patients, the PSA level returned to 4 ng/mL or less before surgery. In 163 patients (35%), the PSA level remained elevated above the reference range and in the remaining 308 patients (65%), the PSA declined to a value below the reference range before surgery. The second most common indication for biopsy was an abnormal digital rectal examination by the referring/primary physician that, when repeated by the attending surgeon, was believed to be normal (n = 155, 22%). Abnormal PSA velocity accounted for biopsy in 68 patients (10%). Among patients with the three most common indications for biopsy, no statistically significant differences in the pathologic tumor characteristics between the groups were noted on the basis of the biopsy indication.
  
  
  CONCLUSIONS
  One in five men undergoing RP at our institution today has T1c disease and a PSA value of 4.0 ng/mL or less. The most common indication for biopsy was an elevated PSA level above their reference range, although in most, the PSA had returned to a normal value before surgery. Regardless of the indication for biopsy, these men had favorable findings at RP. That 22% of patients underwent biopsy because of what was perceived to be an abnormal digital rectal examination underscores the need to continue to perform digital rectal examination along with PSA determination as a part of routine prostate cancer screening.
authors.affiliation: James Buchanan Brady Urological Institute, Department of Urology, Johns Hopkins School of Medicine, Baltimore, Maryland 21287-2101, USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Freedland
authors.forename: Leslie A
authors.initials: LA
authors.lastname: Mangold
authors.forename: Jonathan I
authors.initials: JI
authors.lastname: Epstein
authors.forename: Alan W
authors.initials: AW
authors.lastname: Partin
mesh_terms: D001706:Biopsy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010173:Palpation / Q000379:methods; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000473:pathology*; D012016:Reference Values
chemical_list: D017430:Prostate-Specific Antigen