Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.

Official Title
-----------------
An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy

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

Intervention / Treatment
-----------------
* Drug: Degarelix 240/80 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has given written informed consent before any trial-related activity is performed. Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy) Is a male patient aged 18 years or older Has a screening serum testosterone level >1.5 ng/mL Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2 Has a screening PSA value of ≥2 ng/mL Has a life expectancy of at least 12 months Exclusion Criteria: Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit Is currently treated with a 5-α-reductase inhibitor Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema Has hypersensitivity towards any component of the investigational medicinal product A marked baseline prolongation of QT/QTcF interval A history of additional risk factors for Torsade de Pointes ventricular arrhythmias Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin Has a known or suspect hepatic, symptomatic biliary disease Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days Has other clinically significant laboratory abnormalities Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse Has a mental incapacity or language barriers precluding adequate understanding or co- operation 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 Has previously participated in any degarelix trial

Ages Eligible for Study
-----------------
Minimum Age: 18 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 240/80 mg<br>The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168. | Drug: Degarelix 240/80 mg<br>* The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.<br>* Other names: FIRMAGON;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 |  | Day 28 to Day 196 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 |  | At day 3 | 
| Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 |  | To Day 28 | 
| Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 |  | Day 56 to Day 196 | 
| Cumulative Probability of no PSA Failure From Day 28 to Day 196 | PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir. | To Day 196 | 
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study. | To Day 196 | 
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value. | To Day 196 |