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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix 240/80 mg

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyoungbuk National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Seoul st. mary's hospital
  • Seoul, Korea, Republic of
    • Korea University Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Health System (Sevrance Hospital)
  • Seoul, Korea, Republic of
    • Yonsei University Health System Gangnam Sevrance
  • Gyunggi-do
    • Pyungchon, Gyunggi-do, Korea, Republic of
      • Hallym University Sacred Heart Hospital
  • Gyungnam
    • Mulgeum-eup, Gyungnam, Korea, Republic of
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Drug: 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 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.; Other Names: FE200486; FIRMAGON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Collaborators: Ferring Pharmaceuticals Korea, Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (ESTIMATE): February 19, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FE200486 CS42