title: Prevalence and clinical significance of prostate cancer among 12,682 men with normal digital rectal examination, low PSA levels (< or =4 ng/ml) and percent free PSA cutoff values of 15 and 20%.
abstract: OBJECTIVE
  To report prevalence and clinical relevance of T1c prostate cancers (PCa) in a selected population of men with serum prostate-specific antigen (PSA) levels < or =4 ng/ml enrolled in a multicenter case-finding protocol.
  
  
  METHODS
  A number of 16,298 men, aged 40-75 years, from the urology units they had been referred to, in most cases (81.6%) for lower urinary tract symptoms, were evaluated. Eighty percent of them had PSA < or =4 ng/ml and about 40% PSA < or =2.5 ng/ml. Patients with PSA < or =2.5 ng/ml and PSA between 2.6 and 4 ng/ml and with percent free PSA < or =15 and < or =20%, respectively, were eligible for biopsy; 28 patients refused it, and 11 patients were excluded from the study because of an abnormal digital rectal examination. Among 403 biopsied men, 82 had PSA < or =2.5 ng/ml (group A) and 321 PSA between 2.6 and 4 ng/ml (group B).
  
  
  RESULTS
  A PCa was found in 109 cases (27.0%): 21 in group A and 88 in group B. 48 (44%) of the 109 patients with a PCa underwent radical prostatectomy: all cancers had a volume >0.5 cm(3), and 41% had a final Gleason sum > or =7; the PCa was organ confined in 34 patients (70.8%) and locally advanced in 14 patients (29.1%), and in 12 patients (25%) positive surgical margins were found.
  
  
  CONCLUSIONS
  Using percent free PSA thresholds of 15 and 20%, 25.6% of the men with PSA < or =2.5 ng/ml and 27.4% of the men with PSA between 2.6 and 4 ng/ml were found to have a PCa, respectively. Most of these cancers, when submitted to radical prostatectomy, were found to be clinically significant. As these cancers are mostly organ confined, these patients are ideal candidates for curative nerve-sparing surgery.
authors.affiliation: Urology Unit, Azienda Ospedaliera Cannizzaro, Catania, Italy. piepepe@hotmail.com
authors.forename: Pietro
authors.initials: P
authors.lastname: Pepe
authors.forename: Paolo
authors.initials: P
authors.lastname: Panella
authors.forename: Francesco
authors.initials: F
authors.lastname: Savoca
authors.forename: Antonio
authors.initials: A
authors.lastname: Cacciola
authors.forename: Letterio
authors.initials: L
authors.lastname: D'Arrigo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Dibenedetto
authors.forename: Michele
authors.initials: M
authors.lastname: Pennisi
authors.forename: Francesco
authors.initials: F
authors.lastname: Aragona
mesh_terms: D000328:Adult; D000368:Aged; D051517:Digital Rectal Examination; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D017430:Prostate-Specific Antigen / Q000097:blood*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology* / Q000601:surgery
chemical_list: D017430:Prostate-Specific Antigen