Factors predicting greater prostate-specific antigen (PSA) increases with use of testosterone gel (T-gel) include age 60 years and older, baseline testosterone (T) ≤250 ng/dL, and percentage of free PSA <20 percent, according to a study published in the Journal of Sexual Medicine.

Abraham Morgentaler, M.D., from Harvard Medical School in Boston, and colleagues evaluated 274 hypogonadal adult men (mean age, 53.5 years) with baseline T concentrations <300 ng/dL, PSA ≤2.5 ng/mL, and a negative digital rectal examination. The men were randomized to receive either once-daily T-gel for T therapy (234 participants) or placebo (40 participants).

The researchers found that baseline mean T values were 247 ng/dL, while mean PSA levels were 0.9 ng/mL and mean percentage of free PSA (%fPSA) was 24.6. Among men treated with T-gel, there were increases in T and PSA (P = 0.0012). Compared to baseline, in the placebo group, T increased, while PSA decreased.

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The PSA increase was greater in men 60 years and older than in men younger than 60 years (P = 0.0006). Mean PSA only changed in men with baseline T ≤250 ng/dL (P = 0.0031). In men with baseline %fPSA <20 percent, PSA increased 0.3 ng/mL, while it increased 0.1 ng/mL in men with %fPSA ≥20 percent.

“Overall, T-gel treatment was associated with a minor increase in PSA, of questionable clinical significance,” the authors write. “Men with T >250 ng/dL and age <60 years demonstrated minimal or no PSA change.”

Several authors disclosed financial ties to the pharmaceutical industry.