3.75 and 7.5 mg leuprorelin acetate depot in the treatment of advanced prostatic cancer: preliminary report. German Leuprorelin Study Group.

In an on-going, non-comparative, open, multicentre phase III study in Germany, 190 patients with advanced prostatic cancer were treated with 3.75 or 7.5 mg leuprorelin acetate depot given subcutaneously or intramuscularly once monthly, with or without concomitant antiandrogen or cytostatic therapy. The two doses and the different routes of administration did not have any significant effects on serum testosterone, dihydrotestosterone, follicle stimulating hormone and luteinizing hormone concentrations, tumour activity or clinical tolerance. Using either dose, the 'no progression' rate (complete remission plus partial remission plus stable disease) was 88.5% overall and was 88.2% in T1-T2 disease and 82.5% in T3-T4 disease after 12 months' treatment. It is concluded that the depot formulation of leuprorelin acetate offers an important alternative in the treatment of advanced prostatic cancer.