Prostatic specific antigen in patients with hypogonadism: effect of testosterone replacement.

Introduction: The effect of parenteral testosterone replacement therapy on prostatic specific antigen (PSA) level or the development or growth of prostate cancer is unclear.

Aim: To assess the effect of testosterone replacement on PSA level in patients with hypogonadism associated with erectile dysfunction (ED).

Methods: A total of 187 male patients above the age of 45 with hypogonadism associated with ED were enrolled in this study. Patients were screened for ED by the erectile function domain of the International Index of Erectile Function (IIEF). Patients underwent routine laboratory investigations, plus total testosterone, and PSA assessment. Replacement treatment with parenteral testosterone every 2-4 weeks for 1 year was instituted. Total testosterone and PSA serum levels were assessed every 3 months during the treatment course.

Results: Mean age +/- SD was 62.8 +/- 11.4. Of the patients 87.7% were sexually active. Of the patients 10.2% had mild, 40.6% had moderate and 49.2% had severe ED. Of the study population, 62.5% had ED complaints for less than 5 years and 84.5% had gradual onset of their complaint. The majority of the patients (91.4%) had either progressive or stationary course while the minority reported regressive course and improvement of the condition. There was a significant increase of the post-treatment testosterone level in comparison to pretreatment level (P < 0.05). No significant increase in the post-treatment PSA level in comparison to pretreatment (P > 0.05). No significant difference between pre- and post-treatment categories of PSA level (normal, borderline, high) in relation to the severity of ED (P > 0.05). There was no significant association between PSA level and the duration of testosterone replacement therapy in the study population (P > 0.05).

Conclusion: The current study demonstrated that the level of PSA was not significantly changed after 1 year of testosterone replacement therapy in patients with hypogonadism associated with ED.