A Study of Degarelix in Patients With Prostate Cancer

A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment

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.

This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months.

The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B.

During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.

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.