Ketoconazole therapy for advanced prostate cancer.

Fifteen patients with biopsy-proven prostate cancer were treated with ketoconazole 400 mg every 8 h. Two patients withdrew from therapy, one for personal reasons and one because a paraspinal mass developed. The other thirteen patients completed at least 6 months of therapy. Ketoconazole greatly reduced the need for analgesics; serum prostatic acid phosphatase levels fell to normal, and testosterone levels were reduced. After 6 months thirteen of fourteen evaluable patients were in remission. The side-effects of ketoconazole therapy were limited.