Total androgen blockade: the United States experience.

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.

RCT Entities:   Population Interventions Outcomes