A Study of Degarelix in Taiwanese Patients With Prostate Cancer

Phase 3

Completed

Brief Summary: A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Current or previous hormone therapy
Is currently treated with 5-α-reductase inhibitor
Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy
Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator
Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial

Arm && Interventions

Group	Intervention	Description
Degarelix	Degarelix	-

Primary Outcome Measures

Name	Time	Method
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3	Day 3	Proportion of participants with testosterone at castrate level (\<= 0.5 ng/mL) at Day 3
Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28	From Day 0 to Day 28	Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28
Cumulative Probability of no PSA Failure	Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168	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.

Locations (10): Taichung Veterans General Hospital
🇨🇳
Taichung, Taiwan
Chi-Mei Foundation Hospital
🇨🇳
Tainan, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳
Kaohsiung, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
🇨🇳
Kaohsiung, Taiwan
Chang Gung Memorial Hospital, Linkuo
🇨🇳
Taoyuan, Taiwan
Taipei Veterans General Hospital
🇨🇳
Taipei, Taiwan
Changhua Christian Hospital
🇨🇳
Changhua City, Taiwan
China Medical University Hospital
🇨🇳
Taichung, Taiwan
Chang Gung Medical Foundation, Chiayi Branch
🇨🇳
Chiayi, Taiwan
National Taiwan University Hospital
🇨🇳
Taipei, Taiwan