Ketoconazole high dose in the hormonal treatment of advanced carcinoma of the prostate. A pilot study

Five previously untreated patients with advanced carcinoma of the prostate were treated with the non-estrogenic antifungal agent Ketoconazole in high doses. A rapid fall in serum testosterone, adrenal androgens and serum prostatic acid phosphatases was recorded accompanied by a striking clinical response with reduction of skeletal pain and improvement of performance status. In one patient this was dramatically shown by reduction of a large pelvic tumor and associated edema of the left lower limb. Side-effects such as weakness, fatigue and loss of appetite made four of the patients withdraw from the study. Serum testosterone and serum prostatic acid phosphatase initially suppressed, increased slowly during the treatment period. Consequently, Ketoconazole as sole therapy in the treatment of advanced carcinoma of the prostate was stopped. However, the initial rapid decrease in serum testosterone and the striking positive clinical effect may possibly be utilized combined with orchiectomy or treatment with LHRH agonist analogues.