Objective:To establish non-inferiority of gonadotropin-releasing hormone degarelix compared with goserelin in suppressing and maintaining castrate testosterone levels from Day 28 to Day 364 in Chinese patients with pr...Objective:To establish non-inferiority of gonadotropin-releasing hormone degarelix compared with goserelin in suppressing and maintaining castrate testosterone levels from Day 28 to Day 364 in Chinese patients with prostate cancer.Methods:This is an open-label,multi-centre study in which men aged18 years were randomised in a 1:1 ratio to once-a-month subcutaneous injection of either degarelix(240/80 mg)or goserelin(3.6 mg)for 12 months.The primary endpoint was difference in 1-year cumulative probability of suppressing testosterone to ≤0.5 ng/mL.Non-inferiority was to be established if the lower 95% confidence interval(CI)limit for difference in cumulative probability between the treatment arms was greater than -10%.Secondary endpoints included cumulative probability of prostate-specific-antigen-progression-free-survival(PSA-PFS).Safety was also assessed.Results:Baseline demographics and disease characteristics were similar between degarelix(n=142)and goserelin(n=141)treatment arms.The difference in cumulative probability of maintaining castrate levels from Day 28-364 was 3.6%(95%CI:-1.5%,8.7%),demonstrating non-inferiority of degarelix.The cumulative probability of PSA-PFS at Day 364 was higher for degarelix(82.3%,95%CI:74.7%,87.7%)versus goserelin(71.7%,95%CI:63.2%,78.5%,p=0.038).Adverse events(AEs)were similar between treatment arms,except for more injection site reactions with degarelix versus goserelin.Four(2.8%)and nine(6.4%)patients discontinued due to AEs in degarelix and goserelin groups,respectively.展开更多
文摘Objective:To establish non-inferiority of gonadotropin-releasing hormone degarelix compared with goserelin in suppressing and maintaining castrate testosterone levels from Day 28 to Day 364 in Chinese patients with prostate cancer.Methods:This is an open-label,multi-centre study in which men aged18 years were randomised in a 1:1 ratio to once-a-month subcutaneous injection of either degarelix(240/80 mg)or goserelin(3.6 mg)for 12 months.The primary endpoint was difference in 1-year cumulative probability of suppressing testosterone to ≤0.5 ng/mL.Non-inferiority was to be established if the lower 95% confidence interval(CI)limit for difference in cumulative probability between the treatment arms was greater than -10%.Secondary endpoints included cumulative probability of prostate-specific-antigen-progression-free-survival(PSA-PFS).Safety was also assessed.Results:Baseline demographics and disease characteristics were similar between degarelix(n=142)and goserelin(n=141)treatment arms.The difference in cumulative probability of maintaining castrate levels from Day 28-364 was 3.6%(95%CI:-1.5%,8.7%),demonstrating non-inferiority of degarelix.The cumulative probability of PSA-PFS at Day 364 was higher for degarelix(82.3%,95%CI:74.7%,87.7%)versus goserelin(71.7%,95%CI:63.2%,78.5%,p=0.038).Adverse events(AEs)were similar between treatment arms,except for more injection site reactions with degarelix versus goserelin.Four(2.8%)and nine(6.4%)patients discontinued due to AEs in degarelix and goserelin groups,respectively.
