(HealthDay News) — Factors predicting greater prostate-specific antigen (PSA) increases with use of testosterone gel include age 60 years and older, baseline testosterone of 250 ng/dL or less and percentage of free PSA lower than 20%, according to a study published in the Journal of Sexual Medicine.
Abraham Morgentaler, MD, from Harvard Medical School in Boston, and colleagues evaluated 274 hypogonadal adult men (mean age, 53.5 years) with baseline testosterone concentrations <300 ng/dL, PSA ≤2.5 ng/mL and a negative digital rectal examination.
The men were randomly assigned to receive once-daily testosterone gel for testosterone therapy (n=234) or placebo (n=40).
The researchers found that baseline mean testosterone values were 247 ng/dL, while mean PSA levels were 0.9 ng/mL and mean percentage of free PSA was 24.6%.
Among men treated with testosterone gel, there were increases in testosterone and PSA (P=.0012). Compared with baseline, in the placebo group, testosterone increased, while PSA decreased. The PSA increase was greater in men aged 60 years and older than in men aged younger than 60 years (P=.0006).
Mean PSA only changed in men with baseline testosterone ≤250 ng/dL (P=.0031). In men with baseline with percentage of free PSA <20%, PSA increased 0.3 ng/mL, while it increased 0.1 ng/mL in men with percentage of free PSA ≥20%.
“Overall, [testosterone gel] treatment was associated with a minor increase in PSA, of questionable clinical significance,” the researchers wrote. “Men with [testosterone] >250 ng/dL and age <60 years demonstrated minimal or no PSA change.”
Several authors disclosed financial ties to the pharmaceutical industry.