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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix 240/80 mg

• Registration Number: NCT01071915
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Study Start: 2010-03
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2012-10-29
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Results First Posted: 2013-02-12
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Degarelix 240/80 mg	Degarelix 240/80 mg	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	To Day 196	PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	To Day 196	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.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	To Day 196	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.

Trial Locations

Locations (11)

Pusan National University Yangsan Hospital; 🇰🇷 Mulgeum-eup, Gyungnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Korea University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyoungbuk National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Pyungchon, Gyunggi-do, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Health System Gangnam Sevrance; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Health System (Sevrance Hospital); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of