Effects of high-dose ketoconazole on patients who have androgen-independent prostatic cancer.

Forty-four patients who had metastatic cancer of the prostate that had not responded to conventional hormonal manipulation were treated with high-dose ketoconazole (600 to 1200 mg/d). All had castrate serum concentrations of testosterone prior to therapy. All patients had been categorized as having progressive cancer on assessment by the criteria of the National Prostatic Cancer Project. After treatment with ketoconazole, 57% were recategorized as having stable disease. The majority showed marked subjective lessening of pain on this therapy. Objective responses were noted but were not consistent. Side-effects were common but tolerable. The mean survival time was 73.3 weeks. Ketoconazole may be a useful palliative adjunct in the treatment of hormone-refractory prostatic cancer.