Rhoden EL, Morgentaler A: Risks of testosterone-replacement therapy and recommendations for monitoring. N Engl J Med 2004;350(5):482-92.
Snyder PJ: Hypogonadism in elderly men-what to do until the evidence comes. N Engl J Med 2004;350(5):440-1 (editorial).
Although a recent Institute of Medicine report found insufficient evidence that testosterone treatment benefits elderly men, the use of testosterone supplementation has increased more than 500% in the United States since 1993. No large long-term study has assessed the benefits and risks of testosterone-replacement therapy.
The authors review major sites of potential risks and medication side effects, along with recommendations for baseline tests and monitoring during therapy. In older men, diagnostic criteria for hypogonadism should be applied more stringently and replacement therapy should target the mid-normal testosterone range for elderly men. Baseline measures of prostate-specific antigen (PSA) and hemoglobin levels, a digital rectal examination (DRE), a screen for sleep apnea, and assessment of voiding symptoms using the International Prostatic Symptoms Score are advised. This monitoring should be repeated every 3 to 6 months during the first year of therapy and yearly thereafter.
Monitoring for signs of prostate cancer is mandatory, and men who have an initial elevated PSA level or abnormal DRE require prostate biopsy before testosterone replacement therapy. Although there is no evidence that higher testosterone levels increase prostate cancer risk, men with hypogonadism may be predisposed to more rapid growth of an occult cancer when serum testosterone levels are normalized, so a lower threshold for prostate biopsy in this population is prudent.