Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix; Degarelix; Degarelix; Degarelix; Degarelix; Degarelix; Degarelix
Intervention description: Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial was to find an optimal dose for a new trial drug - degarelix
      (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was
      studied. Patients participating were treated with FE200486 on one occasion. Thereafter they
      came in for visits following a specific schedule until blood samples showed that there was no
      further effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained before any trial related procedures

          -  Male patient with proven prostate cancer in need for endocrine treatment, except for
             neoadjuvant hormonal therapy

          -  ECOG score to be equal to or above 2

          -  Testosterone level within age-specific normal range

          -  PSA value equal to or above 2 ng/ml

          -  Life expectancy of at least 6 months

        Exclusion Criteria:

          -  Previous or current hormonal treatment of prostate cancer

          -  Recent or current treatment with any drugs modifying the testosterone level

          -  Candidate for curative treatment such as prostatectomy or radiotherapy

          -  History of severe asthma, anaphylactic reactions or Quincke's Oedema

          -  Hypersensitivity towards any component of FE200486

          -  Cancer disease within the last ten years except for prostate cancer and some skin
             cancers

          -  Signs of liver impairment shown as elevated serum ALT or serum bilirubin

          -  Other laboratory abnormalities that judged by the investigator would interfere with
             the patients participation in the trial or the evaluation of the trial results

          -  Presenting with significant neurological, gastrointestinal, renal, hepatic,
             cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological,
             dermatological or infectious disorder. In addition any other condition such as
             excessive alcohol or drug abuse that may interfere with trial participation or
             influence the conclusion of the trial as judged by the investigator

          -  Mental incapacity or language barrier

          -  Having received an investigational product within the last 12 weeks preceding the
             trial

          -  Previous participation in this trial