Enzalutamide in Patients With High-risk Prostate Cancer

Inclusion Criteria

• Understand and voluntarily sign an informed consent form.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Histologically confirmed adenocarcinoma of the prostate.
• Patients must have undergone a Radical Prostatectomy (any surgical technique is permitted) within 3 months from study entry and have high-risk disease define by any of the following:
• Pathological stage T3a, T3b, T4 (any grade or iPSA)
• Gleason' sum ≥ 8 (any stage or iPSA)
• Initial Pre-operative PSA ≥ 20ng/mL (any GS or pT stage)
• Any stage/PSA/Gleason patients with a 35% or greater chance of biochemical failure at 5 years based on Kattan's nomogram http://nomograms.mskcc.org/Prostate/PostRadicalProstatectomy.
• Patients with Lymph node (LN) positive disease, regardless of iPSA, pT stage or GS provided their post-operative PSA 6-8 weeks after surgery is ≤ 0.4ng/mL. (Lymph node dissection is desired but not mandated)
• Able to swallow the study drug and comply with study requirements.
• Patients must have normal organ and marrow function as defined below:
• Testosterone ≥ 50 ng/dL per laboratory reference range
• Baseline Post-RP PSA ≤ 0.4
• Hemoglobin ≥ 10.0 g/dL independent of transfusion
• Absolute neutrophil count ≥1,500/mcL
• Platelet count ≥100,000/ìL
• Serum albumin ≥ 3.5 g/dL
• Serum potassium ≥ 3.5 mmol/L
• Liver function: serum bilirubin 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit
• Gastrointestinal disorder affecting absorption (e.g., Gastrectomy, active peptic ulcer disease within last 3 months)
• Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
• The effects of enzalutamide on the developing human fetus at the recommended therapeutic doses are unknown. Thus, men must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 6 months after the usage of enzalutamide. Should the patient's partner become pregnant or suspect she is pregnant while the patient is participating in this study, the patient should inform his treating physician immediately.