Study on the Safety and Effectiveness of Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

• Diagnosed with prostate cancer that has not spread and does not have certain rare cell types.
• Currently receiving hormone therapy to lower testosterone levels or have had surgery to remove the testicles.
• Low testosterone levels at the start of the study.
• Cancer is progressing despite hormone therapy.
• Prostate-specific antigen (PSA) level of at least 2 ng/mL.
• PSA levels are doubling in 10 months or less.
• No evidence of cancer spreading to other parts of the body.
• No symptoms from prostate cancer.
• Good overall health with an ECOG performance status of 0 or 1.
• Expected to live at least 12 more months.

Exclusion Criteria

• Have had chemotherapy for prostate cancer.
• Have used other hormone or biological therapies for prostate cancer recently.
• Have cancer that has spread to the brain or spinal fluid.
• Have had another invasive cancer in the past 3 years.
• Low blood cell counts or low hemoglobin levels.
• High bilirubin or creatinine levels in the blood.
• Low albumin levels in the blood.
• History of seizures or conditions that increase seizure risk.
• Significant heart disease.
• Digestive issues affecting medication absorption.
• Major surgery in the past 4 weeks.
• Allergic to enzalutamide or its ingredients.
• Any other health condition that could interfere with the study or pose a risk to the patient.