[Androgen substitution in men from the urologic point of view]

Androgen substitution has been intensively debated due to major concerns with respect to unknown interactions with prostate cancer initiation and progression. Certainly, androgen substitution should be considered in men with symptomatic hypogonadism (< 1% of men) in whom prostate cancer has been excluded. Serum PSA values should not exceed the currently employed age specific reference values (40-50 years: 2.5 ng/ml, 50-60 years: 3.5 ng/ml, 60-70 years: 4.5 ng/ml and over 70 years: 6.5 ng/ml). A family history of prostate cancer and/or prostatic intraepithelial neoplasia (PIN) should be considered as relative contraindications. If androgen substitution is to be initiated, serum PSA should be monitored at 3 month intervals including digital rectal examinations (DRE). In case of abnormal results (PSA and/or DRE) substitution therapy should be terminated and random prostate biopsies performed. In addition, major issues regarding the optimal substitution pathway (transdermal versus intramuscular versus implants versus oral) remain unclarified and require further investigation. Furthermore, little is known about the precise type and dosage of androgens to be substituted. Lastly, only 10%-18% of men with hypogonadism are symptomatic, reducing the number of patients in whom substitution therapy may be an option significantly. Although substitution therapy is valuable in selected men, unclear issues related to prostate cancer initiation and progression, timing, type and dosage of androgen substitution raise major concerns and need further investigation. Meanwhile patients need to be counselled and advantages balanced against disadvantages, side effects and potential risks.