Androgen replacement therapy and prostate safety.

Progress in the understanding of the action of exogenous testosterone has diminished many of the concerns that existed regarding its safety. The major interest is now focused on the effects of androgen supplementation on the prostate gland. Many such concerns have been addressed but others remain to be fully elucidated. It is well established that hypogonadal men receiving adequate androgen therapy develop a prostate with a volume similar to what would be expected from their eugonadal counterparts. Androgen therapy results in modest elevations in the PSA and minor changes in flow parameters. Prostate cancer, on the other hand, remains the most prominent of the safety concerns. Although there is no evidence that normal levels of testosterone promote the development of cancer of the prostate, it is clear that the administration of testosterone enhances a pre-existing prostatic malignancy. Androgen supplementation studies have been, in most cases, of short duration and lacked a control cohort. The current evidence does not support the view that appropriate treatment of hypogonadal elderly men with androgens has a causal relationship with prostate cancer. Larger experience, however, is needed. The same criteria applies to the use of other hormones such as dehydrotestosterone, dehydroepiandrosterone follicle stimulating and growth hormone. A set of recommendations regarding androgen replacement therapy and prostate safety is proposed.