Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix; Degarelix; Degarelix
Intervention description: One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.; One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.; One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.; One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Androgen ablation therapy

Summary:

      Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity
      to continue treatment with degarelix under a clinical study until FE200486 was available on
      the market or until the study was discontinued.

      Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of
      FE200486.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet the following inclusion criteria before entry into the study:

          -  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 had sufficient testosterone suppression (as defined in the withdrawal criteria of
             FE200486 CS06) for at least 28 days.

        Exclusion Criteria:

        Any patient meeting any of the following exclusion criteria will not be entered into the
        study:

          -  Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to
             achieve at least 28 days of testosterone suppression, insufficient prostate-specific
             antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of
             concomitant rise in testosterone level or non-compliance with protocol required
             procedures.

          -  Requires hormonal therapy for neoadjuvant purposes.

          -  Requires treatment with any other drug modifying the testosterone level or function.

          -  Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or
             radiotherapy, within 6 months after Visit 1.

          -  Has a history of severe asthma requiring daily treatment with inhalation steroids,
             angioedema or anaphylactic reactions.

          -  Has hypersensitivity towards any component of the investigational product.

          -  Has had a cancer disease within the last 10 years except for prostate cancer, and
             surgically removed basocellular or squamous cell carcinoma of the skin.

          -  Has a clinically significant neurologic, gastrointestinal, renal, hepatic,
             cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological,
             dermatological or infectious disorder or any other condition, including excessive
             alcohol or drug abuse, which may interfere with trial participation or which may
             affect the conclusion of the study, as judged by the investigator.

          -  Any 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 (liver transaminases and bilirubin must be within normal
             limits).

          -  Has a mental incapacity or language barrier precluding adequate understanding or
             co-operation.