Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

Prior treatment

• Prior cytotoxic chemotherapy;
• Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
• Major surgery within 4 weeks of randomization;
• Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

Other illness

• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another invasive cancer within 3 years of randomization;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Gastrointestinal disorder affecting absorption;
• Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;

Lab values

• Absolute neutrophil count \< 1000/μL, platelet count \< 100,000/μL, or hemoglobin \< 10 g/dL (6.2 mmol/L) at screening;
• Total bilirubin ≥ 1.5 times the upper limit of normal;
• Creatinine \> 2 mg/dL (177 µmol/L) at screening;
• Albumin \< 3.0 g/dL (30 g/L) at screening;

• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
• Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
• Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
• Progressive disease on androgen deprivation therapy at enrollment;
• PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
• PSA doubling time ≤ 10 months;
• No prior or present evidence of metastatic disease;
• Asymptomatic prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Estimated life expectancy ≥ 12 months.