BICALUTAMIDE IN THE TREATMENT OF ADVANCED PROSTATIC-CARCINOMA - A PHASE-II NONCOMPARATIVE MULTICENTER TRIAL EVALUATING SAFETY, EFFICACY ANDLONG-TERM ENDOCRINE EFFECTS OF MONOTHERAPY

Purpose: The safety, efficacy and pharmacokinetics of bicalutamide wer e investigated in 150 patients with stage D2 prostate cancer. Material s and Methods: Patients received 50 mg. bicalutamide daily in an open label multicenter North American trial. Results: The objective respons e rate (modified European Organization for Research in Cancer Therapy criteria) was 70%. Of 150 patients 59 (39%) met prostate specific anti gen criteria for partial response, and 88 (59%) reached treatment fail ure end points and withdrew. Extent of disease was a significant predi ctor of response but baseline testosterone was not. Breast pain and gy necomastia developed in 76% and 60% of patients, respectively. Mean dr ug plasma concentration was 8,528 +/- 2,928 ng./ml. Conclusions: Bical utamide (50 mg.) daily was well tolerated and efficacious, However, su boptimal effects on prostate specific antigen have led to additional t rials to evaluate monotherapy at higher doses.