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 elevated PSA levels and negative prostate cancer biopsies. Conducted from 2004 to 2006, 80 subjects were enrolled and divided into three groups: Bic 50 mg/week, Bic 100 mg/week, and a control group. 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. Although Ki67 expression was higher in HG-PIN lesions, it was not affected by Bic. Bcl-2 expression increased in treated subjects, and PSA levels decreased by over 30% with Bic treatment. Hormone levels increased by 50-60% on Bic, which was well tolerated with mild side effects. The study concluded that weekly Bic is active and safe, with 50 mg/week recommended for future trials.