Ketoconazole therapy in advanced prostatic cancer.

To determine the effect of ketoconazole, a nonestrogenic antifungal agent, in patients with metastatic prostatic cancer 13 patients with symptomatic stage D2 prostatic cancer were administered 400 mg. ketoconazole orally every 8 hours. By 24 hours of treatment serum testosterone had decreased to the castrate level and the adrenal androgens, androstenedione and dehydroepiandrosterone, also had decreased significantly. By 1 week of treatment clinical response was evident in all patients. Pain was improved and serum prostatic acid phosphatase levels had decreased significantly, and by 1 month prostatic acid phosphatase had reached the normal range. The patients have been followed for 3 to 10 months without relapse. Side effects were few. Because of the ease of administration, rapidity of action, and decrease of adrenal and testicular androgen levels, as well as the relative lack of side effects, ketoconazole may prove to be an important new drug in the treatment of prostatic cancer.