Degarelix Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer

Inclusion Criteria:

• Histologic confirmation of prostatic adenocarcinoma by MSKCC inclusive of the following:
• 3 or more positive biopsy cores
• At least 2 cores containing ≥3 mm of tissue with carcinoma
• A primary tumor Gleason score ≥ 7
• Adequate primary biopsy tissue available for protocol required analysis
• Non-castrate testosterone level (>150 ng/dL)
• Planning to have a radical prostatectomy (RP) at MSKCC
• Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for RP
• Normal organ function with acceptable initial laboratory values:
• WBC >3000/μL
• Platelets >150,000/μL
• Creatinine <2 mg/dL
• Bilirubin <1.5 X ULN (institutional upper limits of normal)
• AST/ALT <2 X ULN
• Karnofsky performance status >70% (Appendix A)
• Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the dose of study drug(s)

Exclusion Criteria:

• Histologic variants in the primary tumor (histologic variants other than adenocarcinoma)
• Current or prior chemotherapy
• Current or prior hormonal therapy (e.g., gonadotropin hormone releasing analogs, megestrol acetate, or antiandrogens) are exclusionary. The use of 5-alpha-reductase inhibitors or steroids must be discontinued within 4 weeks of degarelix injection
• Herbal medications administered with the intent to treat the patient's malignancy within 4 weeks of degarelix injection
• Current or prior radiation therapy to the prostate
• Active infection or intercurrent illness
• Concomitant therapy with any other experimental drug