Efficacy and safety of Bicalutamide 150 mg as the monotherapy in the treatment of locally advanced prostate cancer

Abstract

Objective To compare the efficacy and safety of anti-androgen monotherapy with medical castration in the treatment of non-metastatic locally advanced prostate cancer patients. Me-thods A randomized, parallel controlled, multi-center study was performed on 58 patients who met the inclusion/exclusion criteria. Of these 58 patients, 28 accepted anti-androgen Bicalutamide 150 mg daily as monotherapy, while 30 accepted Goserelin 3.6 mg monthly only as medical castration. The duration of treatment lasted for 12 weeks. The primary efficacy index was the inhibition rate of pros-tate specific antigen (PSA) level after the treatment, and the reduction rate of prostate volume after treatment was used as secondary efficacy index. Adverse events were closely monitored and recorded during the treatment while safety evaluation was performed as well. Results The two randomized treatment groups were well balanced in terms of demographics and baseline characteristics. After 12 weeks of treatment, the serum total PSA level in both groups decreased significantly compared with each baseline data. In Bicalutamide 150 mg group, the median total PSA level decrease was from 36.45 to 2.39 ng/ml, and the PSA inhibition rate was 62.18%. In medical castration group, the me-dian total PSA decrease was from 30.43 to 1.77 ng/ml, and the inhibition rate was 68.03%. There was no significant difference between the 2 groups in terms of total PSA decrease and PSA inhibition rate (P=0.79). By the meantime, prostate volumes decreased significantly in both groups comparing with baseline data. The reduction rate of prostate volume in Bicalutamide group and medical castration group were 36.23% and 42.95%. There was no significant difference between the 2 groups (P=0.36) as well. The incidences of adverse events were similar in the 2 groups, which were 10.7% and 13.3 % for Bicalutamide group and the medical castration group, respectively. Conclusions Bicalu-tamide 150 mg daily in the treatment of non-metastatic locally advanced prostate cancer provides com-parable efficacy with medical castration in regard of decreasing PSA level and reducing prostate vol-ume. It is a safe and well tolerated treatment option as well. Key words: Prostatic neoplasms; Carcinoma; Hormonal therapy; Bicalutamide