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Six-Month Testosterone Therapy May Not Affect Prostate

Study found little impact on tissue androgens or other biomarkers

TUESDAY, Nov. 14 (HealthDay News) -- Six months of testosterone replacement therapy (TRT) normalizes serum androgen levels in older men with late-onset hypogonadism while having little effect on prostate tissue, according to a report in the Nov. 15 Journal of the American Medical Association. The findings were announced Nov. 14 at a special American Medical Association men's health briefing in New York City.

The study, led by Leonard S. Marks, M.D., of University of California Los Angeles School of Medicine and the Urological Sciences Research Foundation in Culver City, Calif., included 44 men ranging from 44 to 78 years of age. All had low serum testosterone (below 300 ng/dL) and related symptoms, and were randomized to receive 150 mg of testosterone enanthate or placebo every two weeks for six months.

Forty of the participants underwent prostate biopsy at baseline and at the end of the trial. TRT boosted serum testosterone to the mid-normal range, while those on placebo recorded no such change, the researchers report. Men receiving TRT displayed no significant rise in prostate tissue levels of either testosterone or dihydrotestosterone. The investigators also detected no change in prostate histology, tissue biomarkers, gene expression, or cancer incidence or severity in patients receiving TRT.

Larger, longer trials are needed to confirm the findings, the researchers stressed. However, based on the findings, they conclude that TRT "does not appear to induce any major biological change in the gland. The prostate risks to men undergoing TRT may not be as great as once believed, especially if the results of pretreatment biopsy are negative."

The study was funded by grants from the U.S. National Institutes of Health, Watson Laboratories of Salt Lake City, and Solvay Pharmaceuticals of Marietta, Ga.

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