Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix 240/80 mg
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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