Comparison of an LH–RH Analogue (Goeserelin Acetate, ‘Zoladex’) with Combined Androgen Blockade in Advanced Prostate Cancer: Final Survival Results of an International Multicentre Randomized–Trial

Objective: The aim of this study was to compare the effects of the nonsteroidal antiandrogen flutamide plus the LH–RH analogue goserelin acetate (combined androgen blockade [CAB]) with goserelin acetate alone in patients with advanced prostate cancer. The original analyses at 25 and 56 months of follow–up have been reported previously, and here we report the final survival analysis after 10 years of follow–up.Methods: 589 patients with advanced prostate cancer (55% with metastatic [M1] and 45% with locally advanced [M0] disease) were randomized to receive goserelin acetate 3.6 mg either alone or in combination with flutamide (250 mg three times daily).Results: A total of 583 patients were included in the analysis. There was a small, but nonsignificant, benefit for CAB compared with goserelin acetate alone in all patients with respect to survival (hazard ratio 0.88, 95% CI 0.73, 1.06). Subgroup analysis of M0 and M1 patients showed similar results (M0: hazard ratio 0.92, 95% CI 0.68, 1.25; M1: hazard ratio 0.85, 95% CI 0.66, 1.08). The treatment effect was not significantly different for M0 and M1 patients (p = 0.685).Conclusions: In this large randomized trial containing significant numbers of M0 patients, after 10 years there was a small but nonsignificant benefit for CAB over castration alone.