A Study of Degarelix in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix; Leuprolide
Intervention description: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.; Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).; Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 409.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to see if giving Degarelix every month for 7 months then stop
      treatment for 7 months (intermittent therapy) would show a reduction of negative effects of
      androgen deprivation therapy by increasing the quality of life while keeping prostate
      specific antigen (PSA) levels suppressed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older.

          -  Raising PSA after prior treatment failure of localized prostate cancer.

          -  Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded)
             based on the most current biopsy.

          -  Has a screening testosterone within normal range (≥1.5 ng/mL).

          -  Has Eastern Cooperative Oncology Group score of ≤2.

          -  Bone scan or CT scan report documenting no evidence of metastasis to the bone or
             internal organs.

          -  Life expectancy of at least 15 months.

        Exclusion Criteria:

          -  Taken hormone therapy in the last 6 months prior to entering this study.

          -  Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a
             stable dose throughout the trial.

          -  Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe
             urticaria and/or angioedema.

          -  Has hypersensitivity towards any component of the study drug.

          -  Has a previous history or presence of another malignancy other than prostate cancer or
             treated squamous/basal cell carcinoma of the skin within the last five years.

          -  Has abnormal laboratory results which in the judgement of the Investigator would
             affect the patient's health or the outcome of the trial.

          -  Has a clinically significant medical condition (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 an intellectual incapacity or language barriers precluding adequate understanding
             or co-operation.

          -  Has received an investigational drug within the last 28 days before the Screening
             visit or longer if considered to possibly influence the outcome of the current trial.

          -  Has received ketoconazole or diflucan in the last 28 days preceding the Screening
             Visit.

          -  Has previously participated in any Degarelix trial.

          -  Is part of an ongoing trial.