(Background) Currently, luteinizing hormone-releasing hormone (LH-RH) agonists and antagonists are used for androgen-deprivation therapy (ADT). However, they are associated with subcutaneous granuloma, rubor, dolor, calor, and eventual ulcer and/or abscess formation. The prevalence of these adverse effects, causes and mechanisms, and effects on serum testosterone levels and clinical outcomes are poorly understood. (Method) We collected the clinical records of men with pathologically diagnosed prostate cancer who were followed in our hospital. The primary aim of the study was to determine the prevalence of granuloma formation, its causes, and the mechanisms involved. The secondary aim was to analyze the effects of subcutaneous induration on serum testosterone levels and clinical outcomes. (Results) Overall, 185 men using leuprorelin (n=161; median age, 75 years), degarelix (n=21; median age, 76), or goserelin (n=3; median age, 76) were analyzed. In the leuprorelin cohort, 51 patients (33.5%) had subjective and/or objective subcutaneous induration and 2 (1.2%) had a large lesion (diameter > 3.0 cm). In the degarelix cohort, 18 patients (85.7%) developed induration and 8 (38%) had a large lesion. One month after the start of ADT, patients in the leuprorelin and degarelix cohorts had median serum testosterone levels that reached the same level as that after castration. There was no significant difference in the overall survival rate between the leuprorelin and degarelix cohorts. There was no significant difference in the serum testosterone level or overall survival rate between patients with or without induration. (Conclusions) The local adverse effects of LH-RH agents are prevalent, but we can regulate the adverse effects by understanding the mechanism involved. The formation of subcutaneous induration did not affect the serum testosterone level or clinical outcome.
Keywords: clinical outcome; luteinizing hormone-releasing hormone; subcutaneous induration.