Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix 240 mg / 80 mg
Intervention description: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this uncontrolled, multi-center, open-label trial was to investigate the
      feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the
      treatment of prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has given written informed consent before any trial-related activity is performed. A
             trial-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), and is in need of androgen deprivation treatment.

          -  Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level
             (measured at a central laboratory) must be >4 ng/mL and ≤50 ng/mL.

          -  Patients with Localised Prostate Cancer or Patients with Previous Therapy with
             Curative Intention and a Rising PSA - PSA doubling time (based on patient records at
             the trial site) must be <24 months. There is no minimum PSA level required and the
             maximum PSA must be ≤50 ng/mL.

          -  Is a male patient aged 18 years or older.

          -  Has an Eastern Cooperative Oncology Group score of ≤2.

          -  Has a life expectancy of at least 24 months.

        Exclusion Criteria:

          -  Has had previous or is currently under hormonal management of prostate cancer
             (surgical castration or other hormonal manipulation, including gonadotropin releasing
             hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase
             inhibitors and estrogens). However, for patients having undergone prostatectomy or
             radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a
             maximum duration of 6 months is accepted. This treatment should have been terminated
             at least 6 months prior to Screening Visit.

          -  Is considered to be candidate for curative therapy, i.e. radical prostatectomy or
             radiotherapy.

          -  Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe
             urticaria and/or angioedema.

          -  Has hypersensitivity towards any component of the investigational medicinal product.

          -  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 suspected clinically significant liver and/or biliary disease.

          -  Has a history of or risk factors for Torsades de Pointes

          -  At time of inclusion receives concomitant medications that might prolong the QT
             interval.

          -  Has any clinically significant laboratory abnormalities which in the judgment of the
             investigator would affect the patient's health or the outcome of the trial.

          -  Has a clinically significant disorder (other than prostate cancer) including but not
             limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological,
             or psychiatric disease, and alcohol or drug abuse or any other condition, which may
             affect the patient's health or the outcome of the trial as judged by the investigator.

          -  Has severe kidney failure (creatinine clearance <30 mL/min), based on the serum
             creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only
             valid in France).

          -  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