A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

Inclusion Criteria: * Prior trial of total androgen blockade * Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide). * Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan * ECOG ≤ 2 * Age ≥ 18 years * Serum testosterone of ≤ 50 mg/dl * PSA ≥ 2.0 ng/ml * White blood cell count ≥ 3000/mm3 * Platelets ≥ 100,000/mm3 * Serum creatinine ≤ 1.5 x upper limits of normal * Bilirubin ≤ 1.5 x upper limits of normal * Alanine transaminase ≤ 1.25 x upper limits of normal * Estimated life expectancy of at least 12 months * Able and willing to sign informed consent Exclusion Criteria: * Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur) * Known allergy to GnRH agonists or antagonists * Previous treatment with Degarelix * Major surgery within 4 weeks of registration * Grade ≥ 3 peripheral neuropathy * Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome * Acute deep vein thrombosis or pulmonary embolism * Taking anti-arrhythmia medication * Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years. * Prior orchiectomy for prostate cancer * PSA \> 100 ng/mL