ANAHEIM, Calif. -- Topical testosterone replacement effectively treats post-prostatectomy hypogonadism with no evidence of serious adverse effects, according to a small trial.
ANAHEIM, Calif., May 24 -- Topical testosterone replacement effectively treats post-prostatectomy hypogonadism with no evidence of serious adverse effects, according to results of a small trial
Daily treatment for a year with topical 1% testosterone gel significantly minimized or eliminated hypogonadal symptoms in prostate cancer patients who had a radical prostatectomy, said Mohit Khera, M.D., of Baylor in Houston, at the American Urological Association meeting here.
Prior to starting treatment, nine of 11 men tested positive for hypogonadism, as assessed by the Androgen Deficiency in Aging Male (ADAM) questionnaire (which assesses signs and symptoms of hypogonadism, such as depression and decreased libido). After a year of topical testosterone replacement, two men had positive ADAM scores,
"Historically, physicians have been reluctant to give testosterone replacement therapy to prostatectomy patients," said Dr. Khera. "There has been a lot of concern that exogenous testosterone might stimulate occult prostate cancer cells left behind after prostatectomy. From this study and others, we now know that is not the case."
The study involved 21 post-prostatectomy patients who met ADAM criteria for hypogonadism. Entry requirements included negative surgical margins and an undetectable PSA level at entry. The primary endpoints were change in PSA value, change in ADAM responses, and change in responses to a modified version of ADAM that allowed respondents to rank each item from 1 (terrible) to 5 (excellent).
Prior to prostatectomy, the study participants' PSA value averaged 6.7 ng/mL, and the average Gleason sum for the cohort was 6.4. The mean time from surgery to the start of testosterone replacement was 54.4 months.
The patients' mean testosterone level before the start of testosterone replacement was 275 ng/mL and increased to 400 ng/mL after 12 months of treatment (P=0.03). PSA values averaged 0.005 ng/mL before and after testosterone replacement. None of the men had a PSA recurrence, said Dr. Khera.
Eleven patients completed the ADAM surveys before and after the study. Scores on the modified ADAM questionnaire averaged 23.7 before testosterone replacement and increased to 32.3 at the end of the study (P=0.01)
The study, though small,, offers physicians and patients an added measure of reassurance about the safety of testosterone replacement, said Dr. Khera. A potentially large patient pool might benefit from testosterone replacement for hypogonadism, which affects about 30% of men older than 50 years of age, he added.