Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer (STRIVE)

Inclusion Criteria:

• Males age 18 or older;
• Histologically or cytologically confirmed adenocarcinoma of the prostate;
• Ongoing androgen deprivation therapy
• Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L) at the Screening visit;
• Progressive disease at study entry defined by PSA progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy
• Asymptomatic or mildly symptomatic from prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Estimated life expectancy of ≥ 12 months;
• Able to swallow the study drug and comply with study requirements.

Exclusion Criteria:

• Severe concurrent disease, infection, or co-morbidity;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another invasive malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer and American Joint Committee on Cancer (AJCC) Stage 0 or Stage 1 cancers that have a remote probability of recurrence;
• Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 9 g/dL at the Screening visit;
• Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) at the Screening visit;
• Creatinine > 2 mg/dL at the Screening visit;
• Albumin < 3.0 g/dL at the Screening visit;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
• Major surgery within 4 weeks of enrollment;
• Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment;
• Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment;
• Prior ketoconazole, abiraterone, or cytotoxic chemotherapy for prostate cancer;
• Use of antiandrogens within 4 weeks prior to enrollment;
• Prior disease progression, as assessed by the Investigator, while receiving bicalutamide;
• Participation in a previous clinical trial of enzalutamide or an investigational agent that inhibits the androgen receptor or androgen synthesis (patients who received placebo are acceptable);
• Use of an investigational agent within 4 weeks of enrollment;
• Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids for prostate cancer within 4 weeks of enrollment;
• 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.