title: Factors influencing prostate-specific antigen response among men treated with testosterone therapy for 6 months.
abstract: BACKGROUND
  Factors influencing prostate-specific antigen (PSA) changes in men undergoing testosterone (T) therapy have not been well studied.
  
  
  OBJECTIVE
  The aim of this study was to assess the influence of selected variables on PSA changes in hypogonadal men administered with 1.62% testosterone gel (T-gel) for 6 months.
  
  
  METHODS
  A double-blind, placebo-controlled study of 274 (234 T-gel, 40 placebo) hypogonadal men >18 years of age, with baseline T concentrations <300 ng/dL, PSA ≤2.5 ng/mL, and negative digital rectal examination. Subjects received once-daily T-gel for T therapy.
  
  
  METHODS
  Changes in mean serum PSA, percentage of free PSA (%fPSA), and T from baseline to 6 months (182 days).
  
  
  RESULTS
  Mean age was 53.5 years and baseline mean values were total T 247 ng/dL, PSA 0.9 ng/mL, and %fPSA 24.6%. Among men treated with T-gel, T increased to 499 ng/dL and PSA increased by 0.1 ng/mL (P = 0.0012). PSA increased ≥0.3 ng/mL in 26.3%, <0.3 ng/mL in 73.7%, including a decline from baseline in 33.0%. In the placebo group, T increased 29 ng/dL to 274 ng/dL, and PSA decreased 0.1 ng/mL, compared with baseline. A greater increase in PSA was noted in men ≥60 years old than in men <60 years old (0.4 vs. 0.05 ng/mL, respectively; P = 0.0006). Mean PSA did not change in men with baseline serum T >250 ng/dL, whereas it increased by 0.2 ng/mL in men with T ≤250 ng/dL (P = 0.0031). PSA increased 0.3 ng/mL in men with baseline %fPSA <20% and 0.1 ng/mL in men with %fPSA ≥20%.
  
  
  CONCLUSIONS
  Overall, T-gel treatment was associated with a minor increase in PSA, of questionable clinical significance. Factors predicting greater PSA increases included age ≥60 years, baseline T ≤250 ng/dL, and %fPSA <20%. Men with T >250 ng/dL and age <60 years demonstrated minimal or no PSA change.
authors.affiliation: Men's Health Boston, Harvard Medical School, Boston, MA, USA.
authors.forename: Abraham
authors.initials: A
authors.lastname: Morgentaler
authors.forename: Janet A
authors.initials: JA
authors.lastname: Benesh
authors.forename: Bela S
authors.initials: BS
authors.lastname: Denes
authors.forename: Natalia
authors.initials: N
authors.lastname: Kan-Dobrosky
authors.forename: Diala
authors.initials: D
authors.lastname: Harb
authors.forename: Michael G
authors.initials: MG
authors.lastname: Miller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D020249:Hormone Replacement Therapy / Q000009:adverse effects; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood*; D013739:Testosterone / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D013739:Testosterone; D017430:Prostate-Specific Antigen
keywords: Androgens; Hormone Replacement Therapy; Prostate-Specific Antigen; Testosterone