A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix; Degarelix
Intervention description: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9; Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9; Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 460.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Androgen ablation therapy

Summary:

      The rationale of the study was to evaluate different degarelix dosing regimens for a
      three-month interval that was to produce and maintain castration in prostate cancer patients
      through immediate and prolonged testosterone suppression, and to provide confirmatory
      evidence of the safety of degarelix.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has given written consent before any study-related activity is performed. A
             study-related activity is defined as any procedure that would not have been performed
             during the normal management of the patient.

          -  Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all
             stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is
             indicated. This includes patients with rising PSA after having undergone prostatectomy
             or radiotherapy with curative intention.

          -  Is a male patient aged 18 years or over.

          -  Has a baseline serum testosterone level above the lower limit of normal range,
             globally defined as >2.2 ng/mL.

          -  Has an ECOG (Eastern Cooperative Oncology Group) score of 2.

          -  Has a PSA value of 2 ng/mL.

          -  Has a life expectancy of at least 13 months.

        Exclusion Criteria:

          -  Has had previous or is currently under hormonal management of prostate cancer
             (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH
             antagonists, antiandrogens, oestrogens). However, patients having undergone
             prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is
             accepted for a maximal duration of 6 months. This treatment should have been
             terminated at least 6 months prior to the Screening Visit.

          -  Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or
             radiotherapy within 13 months from Screening Visit.

          -  Has a history of, or predisposition to, severe hypersensitivity reactions such as
             severe asthma (defined as a need for daily treatment with inhalation steroids to
             control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or
             angioedema.

          -  Has hypersensitivity towards any component of the investigational medicinal product.
             5. Has had a cancer disease within the last five years except for prostate cancer and
             surgically removed basal or squamous cell carcinoma of the skin.

          -  Has a known or suspected hepatic or symptomatic biliary disease.

          -  Has elevated serum ALT level above upper level of normal range or serum total
             bilirubin level above upper level of normal range as measured by the laboratory at the
             Screening Visit.

          -  Has other clinically significant laboratory abnormalities, which in the judgment of
             the investigator would interfere with the patient's participation in this study or
             evaluation of study results.

          -  Has a clinically significant disorder (other than prostate cancer) or any other
             condition, including excessive alcohol or drug abuse, which may interfere with study
             participation or which may affect the conclusion of the study as judged by the
             investigator.

          -  Has a mental incapacity or language barriers precluding adequate understanding or
             cooperation.

          -  Has received an investigational drug within the last 28 days preceding Screening Visit
             or longer if considered by the investigator to possibly influence the outcome of the
             current study.

          -  Has previously participated in any degarelix study.