Ketoconazole as primary treatment of prostatic cancer.

Ketoconazole 400 mg 8-hourly was used as primary hormonal treatment in 12 patients with advanced prostatic carcinoma. Four patients were withdrawn because of side effects and 1 died. The 7 patients who tolerated the drug had a reduction in testosterone and adrenal androgens. Six patients were fully evaluable. There was one partial response with complete remission of symptoms. Two patients enjoyed a subjective response and 3 showed no response. Ketoconazole had an effective biochemical action but the side effects seen in this study severely limit its usefulness. Ketoconazole has now been withdrawn as a treatment for prostatic cancer. However, less toxic derivatives might prove a useful addition to the drugs available to treat this condition.