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