589 patients from 10 countries are recruited into a multicentre randomised trial comparing Zoladex with a combination of Zoladex-Depot + flutamide. Zoladex was administered as a depot injection every 28 days and flutamide was given as 3 x 250 mg tablets daily. Patients with histologically confirmed locally advanced (T3/T4) or metastatic (M1) carcinoma were included. Patients with previous hormonal manipulation and/or chemotherapy were excluded. 65% of patients had metastatic disease. Both treatment groups were balanced (T-category, histology, metastases, performance status). An analysis of subjective and objective response, time to response and time to progression has shown no statistically significant difference. A survival analysis after a median follow-up of 24 months has shown no statistically significant difference between the two treatment groups (p = 0.47).