A Study of Degarelix in Patients With Prostate Cancer

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.

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.