Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Inclusion Criteria

• Men with metastatic castration-resistant prostate cancer
• Progressive disease on androgen deprivation therapy
• Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
• ECOG performance score ≤ 1
• Estimated life expectancy of ≥ 12 months

Exclusion Criteria

• Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
• Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
• History of brain metastasis, active leptomeningeal disease or seizure
• Severe cardiovascular or hepatic disease
• Pituitary or adrenal dysfunction

Trial Phase Phase IV

Trial Type Treatment

Lead Organization
Pfizer Inc

• Primary ID MDV3100-10
• Secondary IDs NCI-2014-01568, 2013-000722-54, C3431013, PLATO, C3431013
• Clinicaltrials.gov ID NCT01995513