Analysis of quality of life after randomized controlled trial of alpha-1 adrenoceptor antagonist alone and in combination with cyclooxygenase-2 inhibitor in patients who underwent low-dose-rate brachytherapy for prostate cancer

PURPOSE: The goal of this study was to evaluate the effect of cyclooxygenase-2 (COX-2) inhibitors on quality of life (QoL) of patients undergoing low-dose-rate (LDR) brachytherapy. MATERIAL AND METHODS: A total of 310 patients with prostate cancer who had undergone LDR brachytherapy were enrolled. The patients were randomized (1 : 1) to the monotherapy group (tamsulosin alone: 0.2 mg/day, n = 156) and the combination group (tamsulosin: 0.2 mg/day plus celecoxib: 200 mg/day, n = 154) without placebo. Using the expanded prostate cancer index composite (EPIC) and medical outcomes study 8-item short form health survey (SF-8) questionnaire, QoL was evaluated at baseline and at 1, 3, 6, and 12 months after seed implantation. RESULTS: The mean changes in scores from baseline to 1 and 3 months after seed implantation for the urinary (1M: –10.5, 3M: –10.9) and bowel (1M: –2.4, 3M: –4.2) domains of EPIC in the combination group were not significantly different from those (urinary 1M: –11.0, 3M: –11.4, bowel 1M: –2.3, 3M: –4.6) in the monotherapy group. The mean changes in scores from baseline to 1 and 3 months after seed implantation for the physical component summary (1M: 0.009, 3M: –0.32) and mental component summary (1M: 0.41, 3M: 0.36) of SF-8 in the combination group were not significantly different from those (physical component 1M: –0.89, 3M: –0.22, mental component 1M: 1.3, 3M: 1.1) in the monotherapy group. CONCLUSIONS: Combination treatment with celecoxib and tamsulosin during the peri-operative period is not warranted for improving QoL in patients undergoing LDR brachytherapy.