[High dosage ketoconazole therapy in the treatment of advanced prostatic cancer]

This paper reports on oral high-dose ketoconazole treatment (3 x 400 mg/die) in 38 patients with advanced (pT3-4NXMOGIII - n = 9), metastasizing (Ml - n = 23) prostatic cancers that had been treated previously (n = 23) or untreated (n = 15). The primary response rate was 66% with 37% remissions. After 1 year, the response rate was 40% with 8% remissions and 8% progressive tumours. There was drop-out rate of 34% because of adverse experience and a very high rate of side-effects for 74%. During treatment there was a significant reduction in testosterone, cortisol and acid phosphatase blood levels. There was a transient rise in liver enzymes (gamma-GT, GOT, GPT, LDH and bilirubin) above the limit. There was no change registered in the renal parameters (BUN, creatinine) or in the calcium and phosphorus blood levels. There was no difference in the response rate between patients who had been treated previously and those with no treatment. There was also no difference in the outcome of tumours that had metastasized and those that had not.