Introduction: Factors influencing prostate-specific antigen (PSA) changes in men undergoing testosterone (T) therapy have not been well studied. Aim: 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 <300ng/dL, PSA≤2.5ng/mL, and negative digital rectal examination. Subjects received once-daily T-gel for T therapy. Main Outcome Measures: 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 247ng/dL, PSA 0.9ng/mL, and %fPSA 24.6%. Among men treated with T-gel, T increased to 499ng/dL and PSA increased by 0.1ng/mL (P=0.0012). PSA increased ≥0.3ng/mL in 26.3%, <0.3ng/mL in 73.7%, including a decline from baseline in 33.0%. In the placebo group, T increased 29ng/dL to 274ng/dL, and PSA decreased 0.1ng/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. 0.05ng/mL, respectively; P=0.0006). Mean PSA did not change in men with baseline serum T>250ng/dL, whereas it increased by 0.2ng/mL in men with T≤250ng/dL (P=0.0031). PSA increased 0.3ng/mL in men with baseline %fPSA<20% and 0.1ng/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≤250ng/dL, and %fPSA<20%. Men with T>250ng/dL and age <60 years demonstrated minimal or no PSA change. Morgentaler A, Benesh JA, Denes BS, Kan-Dobrosky N, Harb D, and Miller MG. Factors influencing prostate-specific antigen response among men treated with testosterone therapy for 6 months.
Bibliographical noteFunding Information:
Conflict of Interest: Janet A. Benesh, Diala Harb, and Michael G. Miller are employees of, and own stock in, AbbVie. Abraham Morgentaler has received research funding from Auxilium, Lilly, and Antares, and has been a consultant for AbbVie, Auxilium, and Antares. He has served on the advisory boards of AbbVie and Auxilium and received lecture honoraria from Bayer and Merck. Bela S. Denes is a former employee of AbbVie. Natalia Kan‐Dobrosky is a former employee of AbbVie and owns AbbVie stock.
© 2014 International Society for Sexual Medicine.
- Hormone Replacement Therapy
- Prostate-Specific Antigen