Effect of flutamide on survival in patients with pancreatic cancer: results of a prospective, randomised, double blind, placebo controlled trial.

OBJECTIVES To assess whether flutamide (Drogenil), a pure androgen receptor blocking agent, improves survival in patients with pancreatic carcinoma and thus whether testosterone is a major growth factor for this tumour. DESIGN A prospective, randomised, double blind placebo controlled trial. SUBJECTS 49 patients with a clinical diagnosis of pancreatic carcinoma. INTERVENTIONS 24 patients received flutamide and 25 received placebo. MAIN OUTCOME MEASURES Death of the patient. RESULTS Analysis of all patients at 6 months and 1 year showed 14 and eight patients alive, respectively, in the flutamide group compared with 10 and one in the placebo group. After exclusion of those patients in both groups who received less than 6 weeks' treatment because of advanced disease and early death the comparable results were 14 (88%) and eight (50%) alive in the flutamide group compared with 10 (50%) and one (5%) in the placebo group. Median survival for all patients was 8 months in the flutamide group compared with 4 months in the placebo group. With the 6 week exclusions median survival was 12 months compared with 5 months, respectively. CONCLUSIONS This study supports the concept that testosterone is a growth factor for pancreatic carcinoma and that blockade of androgen receptors offers an appropriate new approach to treatment.