A controlled trial of leuprolide with and without flutanide in prostatic carcinoma

Whether or not chemically blocking the action of male hormones makes the treatment of prostate cancer more effective was investigated. Six hundred and three men being treated for prostate cancer with leuprolide acetate, which inhibits the release of growth hormone, were evaluated in a randomized, double-blind test. Half the men also received flutamide, which blocks the action of male hormones. The flutamide-treated men survived 16.5 months without worsening of their cancer, compared with 13.9 months in men not treated with flutamide. Flutamide-treated men survived an average of 36 months, versus 28 months for untreated men. The differences in the progression of the cancers in treated and untreated men were particularly pronounced in men who had minimal disease and good physical performance, meriting further studies on these patients. The patients were most relieved during the first three months of flutamide treatment. During this period, leuprolide alone often causes the disease to flare-up painfully. It was concluded that, in patients with advanced prostate cancer, a combination of flutamide and leuprolide is preferable to treatment with leuprolide alone.