Phase I-II Trial of Weekly Bicalutamide in Men with High PSA and Negative Biopsy

The study evaluated the activity and safety of weekly low-dose bicalutamide (Bic) in men with high PSA levels and negative prostate cancer biopsies. A total of 80 subjects were enrolled and divided into three groups: 50 mg/week Bic, 100 mg/week Bic, and a control group with no treatment. Results showed a decrease in high-grade prostatic intraepithelial neoplasia (HG-PIN) and proliferative inflammatory atrophy (PIA) in the treated groups, while these conditions increased in the control group. Complete remission of HG-PIN was more common in treated subjects. Bicalutamide was associated with a significant decrease in PSA and prostatic acid phosphatase levels, and an increase in testosterone, LH, estradiol, and SHBG. The treatment was well tolerated, with mild breast pain and gynecomastia reported in 40% of treated subjects. The study concluded that weekly Bic is active and safe, with the 50 mg/week dose recommended for future trials.