Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

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

See trial information on ClinicalTrials.gov for a list of participating sites.

Lead Organization
Pfizer

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