A Study of Degarelix in Taiwanese Patients With Prostate Cancer

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

Official Title
-----------------
An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Degarelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years or older Has a histological confirmed prostate cancer Has a screening serum testosterone above 1.5 ng/mL Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2 Has a screening PSA value of ≥2 ng/mL Has a life expectancy of at least 168 days 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix<br> | Drug: Degarelix<br>* 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).<br>* Other names: FE200486;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Day 28 to Day 168 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168 |