of 5-alpha reductase inhibitor (e.g., finasteride) and a pure antiandrogen (e.g., Hideyuki Akaza 1 casodex) on rat prostate carcinogenesis and to determine whether latent prostate Mizuki Onozawa 1 carcinoma can be prevented to develop to clinically significant cancer by use of Tomoyuki Shirai 2 these drugs. Yukitaka Ideyama 3 METHODS. F344 rats were subcutaneously administered 3,2-dimethyl-4-aminobi-phenyl (DMAB) for the first 20 weeks and testosterone propionate throughout the 1 Department of Urology, Institute of Clinical 60-week study. Finasteride (5 mg/kg and 15 mg/kg, 2 times per week) and casodex Medicine, University of Tsukuba, Tsukuba, Ibar-(15 mg/kg, 30 mg/kg, and 60 mg/kg, 3 times per week) were administered orally aki, Japan. during the last 40 weeks of the study. Tumors were classified as visible prostate 2 First Department of Pathology, Nagoya City carcinoma when they could be recognized with the naked eye and as microscopic University, Nagoya, Aichi, Japan. prostate carcinoma when detectable only with a microscope. 3 Endocrinology and Metabolic Disease Re-RESULTS. The incidence of visible prostate carcinoma was 51% (18 of 35 rats) in search Laboratory, Institute for Drug Discovery the positive control group, whereas it was 40% (4 of 10 rats) in the finasteride 5 Research, Yamanouchi Pharmaceutical Co., mg/kg group, 16.7% (2 of 12 rats, P Å 0.0091) in the finasteride 15 mg/kg group, Ltd., Tsukuba, Ibaraki, Japan. 20% (4 of 20 rats, P Å 0.05) in the casodex 15 mg/kg group, 14.3% (3 of 21 rats, P Å 0.0008) in the casodex 30 mg/kg group, and 0% (0 of 11 rats, P Å 0.0002) in the casodex 60 mg/kg group. On the other hand, when visible carcinomas and microscopic carcinomas were handled together, only casodex 60 mg/kg significantly inhibited the carcinogenesis rate. CONCLUSIONS. Finasteride achieved dose-dependent inhibition of macroscopic rat prostate carcinogenesis, and casodex also inhibited macroscopic prostate carcino-genesis. However, both drugs showed insufficient prevention of carcinogenesis at the microscopic level. These findings indicate that, in clinical medicine as well, such drugs may also be able to prevent the progression of latent prostate carcinoma to life-threatening disease.