title: Early detection of recurrent prostate cancer with an ultrasensitive chemiluminescent prostate-specific antigen assay.
abstract: OBJECTIVE
  Treatment failure after radical prostatectomy is most commonly heralded by an increase in serum prostate-specific antigen (PSA) to detectable levels. We evaluated the clinical utility of an ultrasensitive chemiluminescent PSA assay.
  
  
  METHODS
  We evaluated the assay in banked sera obtained from 170 men after radical prostatectomy. Controls consisted of 142 females, 29 men who had undergone cystoprostatectomy without evidence of prostate cancer, and 25 men without evidence of recurrent disease at least 5 years after prostatectomy for organ-confined disease. Lead time to diagnosis of recurrence was based on comparisons with the IMx or Tandem E assays using a cutoff of 0.1 ng/mL (100 pg/mL).
  
  
  RESULTS
  The biologic level of detection of this assay is 8 pg/mL. Serum PSA levels were undetectable in 82.4% of females, 86.2% of the cystoprostatectomy patients, and 96% of the radical prostatectomy controls. After radical prostatectomy, PSA levels were undetectable at last check in 104 of 168 (61.9%) men. In the 24 men with prostate cancer recurrence, the enhanced sensitivity of 8 pg/mL provided a mean lead time based on conservative calculations of 12.7 to 22.5 months over conventional assays. Thirty-four of the 41 men with detectable PSA levels and no evidence of disease recurrence had PSA levels of 30 pg/mL or less.
  
  
  CONCLUSIONS
  PSA levels are undetectable in most men who do not have recurrence of disease after radical prostatectomy. Low but detectable serum PSA levels less than or equal to 30 pg/mL can be produced by nonmalignant sources of PSA. PSA assays with enhanced sensitivity can detect recurrent prostate cancer with significant lead time over conventional assays.
authors.affiliation: Department of Urology, University of Washington, Seattle VA Medical Center, 98195, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: Ellis
authors.forename: R L
authors.initials: RL
authors.lastname: Vessella
authors.forename: J L
authors.initials: JL
authors.lastname: Noteboom
authors.forename: P H
authors.initials: PH
authors.lastname: Lange
authors.forename: R L
authors.initials: RL
authors.lastname: Wolfert
authors.forename: H G
authors.initials: HG
authors.lastname: Rittenhouse
mesh_terms: D005260:Female; D006801:Humans; D008163:Luminescent Measurements; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000097:blood* / Q000175:diagnosis*; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis*; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D017430:Prostate-Specific Antigen