Objectives: To determine the anti-androgenic effects and safety of the combination of finasteride and flutamide in men with prostate cancer.
Patients and methods: Seventeen men with various stages of prostate cancer, all of whom were candidates for androgen deprivation therapy, were treated with finasteride plus flutamide and were followed for a mean of 13.6 months using measurements of serum prostate specific antigen (PSA), and an assessment of regression and side-effects.
Results: The initial median PSA level was 19.8 ng/mL: at 3, 6 and 12 months the median PSA had fallen to 1.2, 0.85 and 0.8 ng/mL, respectively. In four patients followed for 2 years, the anti-neoplastic effects were sustained. Patients with initially palpable disease had regression, as assessed by a digital rectal examination. Side-effects included gynaecomastia (five patients), mildly elevated hepatic transaminases (two) and diarrhoea (one). Most men maintained their previous sexual function.
Conclusions: Early results suggest that the combination of finasteride and flutamide provides significant anti-androgenic therapy and maintains sexual function in most men. A further investigation with more patients and a longer follow-up is warranted.