a study of degarelix in patients with prostate cancer

Conditions: Prostate Cancer

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.

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.