TRT in middle-aged hypogonadal men: Vigilance advised

May 21, 2007

The authors of a study from the University of North Carolina, Chapel Hill, suggest that physicians treating middle-aged hypogonadal men with extrinsic testosterone should be more vigilant in monitoring these patients' PSA levels than they would be in monitoring non-hypogonadal men of the same age.

The authors of a study from the University of North Carolina, Chapel Hill, suggest that physicians treating middle-aged hypogonadal men with extrinsic testosterone should be more vigilant in monitoring these patients' PSA levels than they would be in monitoring non-hypogonadal men of the same age.

"Testosterone is a safe treatment. The only caveat is that in men aged 50 or older, doctors should be vigilant about prostate cancer," lead author Culley C. Carson, III, MD, told Urology Times.

Dr. Carson noted that a primary concern in male testosterone therapy is that, theoretically, the hormone might increase the risk of prostate cancer. To test the theory, he and his colleagues followed 81 hypogonadal men with normal baseline PSAs who were receiving testosterone for 33.8 ±29.7 months.

Of the 81 men enrolled in the study, four were diagnosed with prostate cancer at an average of 32.5 months (range, 22 to 41 months) after entering the study. PSA in these men showed a 1.8 ng/mL rise from baseline at 18 months and a 3.2 ng/mL rise at 36 months. Only the latter increase achieved statistical significance (p=.047), Dr. Carson's team reported at the AUA annual meeting.

"We were surprised that the PSA took so long to rise. It took an average of 28 months before these men evidenced a significant increase in their PSA," Dr. Carson told Urology Times.

Dr. Carson does not think that the hormone treatment initiated the cancer.

"I think its appearance had little to do with the administration of the medication," he said. "Testosterone is a safe treatment."

The advantage of semiannual PSA screening is that it provides more data for velocity curves, allows a significant PSA rise to be detected earlier, and subsequently allows for an earlier diagnosis and treatment, Dr. Carson said.

Dr. Carson is a consultant/adviser to Auxilium Pharmaceuticals and Solvay Pharmaceuticals.