Abstract
Maximal androgen blockade may improve the effectiveness of treatment of prostate cancer. To test this hypothesis we conducted a randomized, double-blind trial in patients with disseminated and previously untreated prostate cancer (stage D2). All patients (n = 603) received leuprolide, 1 mg/day s.c. in combination with either placebo (n = 300) or flutamide 250 mg p.o. t.i.d. (n = 303). The median progression-free survival times were estimated at 14 months for the leuprolide plus placebo group and 17 months for leuprolide plus flutamide patients: median times for overall survival were 29 vs. 35 months, respectively. Patients with minimal disease and good performance status did particularly well on combination therapy. Median progression-free survival for this subgroup was 19 months for leuprolide plus placebo patients vs. 48 months for patients on combined therapy (p = 0.035) Flutamide appeared to reduce the disease flare associated with leuprolide monotherapy. Combined androgen blockade with leuprolide and flutamide is superior to leuprolide treatment alone in patients with disseminated prostate cancer.
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