A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
Changhua Christian Hospital
Changhua, Taiwan
Chang Gung Medical Foundation, Chiayi Branch
Chiayi City, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.
Time frame: From Day 28 to Day 168
Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3
Proportion of participants with testosterone at castrate level (\<= 0.5 ng/mL) at Day 3
Time frame: Day 3
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28
Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28
Time frame: From Day 0 to Day 28
Cumulative Probability of no PSA Failure
The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.
Time frame: Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168
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Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi-Mei Foundation Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkuo
Taoyuan District, Taiwan