title: Significance of free prostate-specific antigen and gamma-seminoprotein in the screening of prostate cancer.
abstract: BACKGROUND
  Since free prostate-specific antigen (PSA) and gamma-seminoprotein (gamma-SM) recognize similar epitope(s) of PSA, the significance of serum-free PSA and gamma-SM in the early detection of prostate cancer was compared.
  
  
  METHODS
  A prospective clinical trial was conducted on 701 male volunteers, age 50 years or older. Free PSA (Tandem-R free PSA, Hybritech) and gamma-SM (gamma-SM, Chugai) levels were determined, and biopsies were performed if the PSA (Tandem-R, Hybritech) level was > 4 ng/ml, or if digital rectal examination (DRE) was suspicious.
  
  
  RESULTS
  One hundred and eighty-seven men (27%) had either a PSA level > 4 ng/ml or a suspicious DRE. Of 116 biopsies performed, cancer was detected in 13 (1.9%, 13/701). Receiver-operating characteristic analysis of free PSA to PSA ratio (free PSA ratio, %) and gamma-SM to PSA ratio (gamma-SM ratio), to differentiate normal biopsy findings from cancer, showed that the optimal values were 12% and 0.38, respectively. Positive predictive value for cancer was 24% (12 cancers/50 biopsies) for PSA alone, 42% (8/19) for the combination of PSA and DRE, 45.5% (10/22) for the combination of PSA and gamma-SM ratio, and 50% (10/20) for the combination of PSA and free PSA ratio. Regression analysis showed that gamma-SM highly correlated with free PSA, but that the analytical detection limit of gamma-SM was 1 ng/ml, significantly higher than that of free PSA.
  
  
  CONCLUSIONS
  Free PSA determination might effectively eliminate unnecessary biopsies in subjects with PSA > 4 ng/ml, and gamma-SM might provide a complementary index to free PSA, but its validity should be further studied in other settings, such as after radical prostatectomy or during endocrine treatment.
authors.affiliation: Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.
authors.forename: E
authors.initials: E
authors.lastname: Higashihara
authors.forename: K
authors.initials: K
authors.lastname: Nutahara
authors.forename: M
authors.initials: M
authors.lastname: Kojima
authors.forename: T
authors.initials: T
authors.lastname: Okegawa
authors.forename: I
authors.initials: I
authors.lastname: Miura
authors.forename: A
authors.initials: A
authors.lastname: Miyata
authors.forename: M
authors.initials: M
authors.lastname: Kato
authors.forename: H
authors.initials: H
authors.lastname: Sugisaki
authors.forename: T
authors.initials: T
authors.lastname: Tomaru
mesh_terms: D000368:Aged; D001706:Biopsy; D006801:Humans; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D010808:Physical Examination; D011237:Predictive Value of Tests; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000032:analysis*; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000517:prevention & control*; D012007:Rectum; D012680:Sensitivity and Specificity
chemical_list: D017430:Prostate-Specific Antigen